Dressing, Wound, Hydrogel Without Drug And/or Biologic
General, Plastic Surgery · 21 CFR 878.4022
Recent MDR events
105 adverse event reports on file
- DUODERM PASTE AND GELSJun 9, 2026MalfunctionConvatec Ltd1000317571-2026-00167
- DUODERM PASTE AND GELSApr 3, 2026MalfunctionConvatec Ltd1000317571-2026-00079
- DUODERM PASTE AND GELSFeb 13, 2026MalfunctionConvatec Ltd1000317571-2026-00021
- DUODERM PASTE AND GELSFeb 12, 2026MalfunctionConvatec Ltd1000317571-2026-00019
- DUODERM PASTE AND GELSSep 2, 2025MalfunctionConvatec Ltd1000317571-2025-00093
- DUODERM PASTE AND GELSAug 28, 2025MalfunctionConvatec Ltd1000317571-2025-00089
- DUODERM PASTE AND GELSAug 14, 2025MalfunctionConvatec Ltd1000317571-2025-00085
- DUODERM PASTE AND GELSAug 1, 2025MalfunctionConvatec Ltd1000317571-2025-00082
- DUODERM PASTE AND GELSAug 1, 2025MalfunctionConvatec Ltd1000317571-2025-00083
- SOLOSITE 50G TUBE CTN 12Mar 6, 2025InjurySmith & Nephew Medical Ltd.8043484-2025-00012
Event type breakdown
Recalls
6 recall events for this product code
- O-Two Medical Technologies, Inc.TerminatedJun 22, 2017
Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 ---
For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief products to prevent potential contamination. .
Z-2731-2017 · View FDA record ↗ - Embeem Inc.TerminatedJan 17, 2007
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peel
Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
Z-0455-2007 · View FDA record ↗ - Safe N Simple, LLCTerminatedUnknown
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
The sterilization process used was unqualified.
Z-0400-2019 · View FDA record ↗ - Safe N Simple, LLCTerminatedUnknown
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
The sterilization process used was unqualified.
Z-0401-2019 · View FDA record ↗ - Nelson Innovaions, LlcOpen, ClassifiedUnknown
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 )
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Z-2083-2020 · View FDA record ↗ - CellEra LLCTerminatedUnknown
VITALE Silicon Foam Dressings 4"x4"
Adhesive border was not sticky enough.
Z-2085-2019 · View FDA record ↗
Registered firms
304 firms currently registered for this product code
Dsh Medical Co., Ltd.
Siheung-si Gyeonggi, KR
Ceva Logistics Netherlands B.v.
Oostrum Limburg, NL
Isomedix Operations Inc.
CHESTER, NY, US
Pure Source, Llc
Doral, FL, US
Span Packaging Services D.b.a. Multi-pack Solutions
Greenville, SC, US
L&r Usa Inc.
Milwaukee, WI, US
Vernon Area Rehabilitation Center, Inc. - Sauk Division
Reedsburg, WI, US
Uan Healthcare Limited
CENTRAL, HK
Bioregen Biomedical (changzhou) Co., Ltd
Changzhou Jiangsu, CN
Cbr Enterprise Limited
Hong Kong, HK
Ningbo Hysent Medical Technology Co., Ltd
Ningbo Zhejiang, CN
Ready Set Import
Beverly Hills, CA, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Safe N Simple Llc
Clarkston, MI, US
Andersen Caledonia Ltd
Bellshill Scotland, GB
Conmed Corporation
WESTBOROUGH, MA, US
Neilmed Pharmaceuticals, Inc.
Santa Rosa, CA, US
Coloplast A/s
HUMLEBAEK Hovedstaden, DK
Guangdong Tidakang Medical Technology Co., Ltd
ZhongShan City Guangdong, CN
Ningbo Tianbo First Aid Product Co., Ltd.
Ningbo Zhejiang, CN
Nanjing Anjian Medical Device Co.,ltd.
Nanjing Jiangsu, CN
Wasip Ltd.
TORONTO Ontario, CA
Rommelag Cdmo Gmbh
Sulzbach-Laufen Baden-Wurttemberg, DE
Nicomedical Co., Ltd.
Yongin-si Gyeonggi, KR
510(k) clearances
29 clearances for this product code
- River'S Edge Pharmaceuticals, LLCJan 8, 2009
K083721 · MODIFICATION TO ZENIEVA
- Gorbec Pharmaceutical Services, Inc.Oct 23, 2008
K082865 · MODIFICATION TO ZENIEVA
- Gorbec Pharmaceutical Services, Inc.Jul 23, 2008
K073246 · ZENIEVA
- Giltech Plus, Inc.Sep 17, 1999
K992094 · GILTECH PLUS HYDROGEL SKIN DRESSING
- Dermaphylyx, Inc.Jun 28, 1999
K991061 · DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
- Ludlow Technical ProductsAug 21, 1997
K972646 · AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
- Coloplast Corp.Jul 29, 1997
K971597 · COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
- North American Sterilization & Packaging Co.Aug 2, 1996
K962352 · HYDROGEL SKIN DRESSING