Protector, Skin Pressure
General Hospital · 21 CFR 880.6450
Recent MDR events
232 adverse event reports on file
- PREVALON TAP 2.0 MULTIPK 3Jul 10, 2026InjurySage Products Llc0001419181-2026-00019
- PRIMOJun 10, 2026MalfunctionShenzhen Zhouyang Medical Care Products Co., -usd3004824601-2025-00186
- PRIMOJun 10, 2026MalfunctionShenzhen Zhouyang Medical Care Products Co., -usd3004824601-2025-00185
- MOLNLYCKE Z-FLEXMar 24, 2026InjuryMolnlycke Health Care3004763499-2026-00004
- PRIMOJan 2, 2026MalfunctionDongguan Guisheng Foam Producing Co3004824601-2026-00011
- SAMMONS-PRESTONDec 29, 2025InjuryDongguan Guisheng Foam Producing Co3004824601-2025-00183
- PRIMODec 20, 2025MalfunctionShenzhen Zhouyang Medical Care Products Co., -usd3004824601-2025-00222
- PRIMODec 20, 2025MalfunctionShenzhen Zhouyang Medical Care Products Co., -usd3004824601-2025-00220
- PRIMODec 20, 2025MalfunctionShenzhen Zhouyang Medical Care Products Co., -usd3004824601-2025-00221
- PRIMODec 20, 2025MalfunctionDongguan Guisheng Foam Producing Co3004824601-2025-00218
Event type breakdown
Recalls
4 recall events for this product code
- Philips Medical Systems, Inc.TerminatedDec 16, 2014
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small),
Mold on gel filled Gel-E and Squishon products
Z-0206-2015 · View FDA record ↗ - Childrens Medical VenturesTerminatedAug 20, 2014
Gel-E Donut, Squishon 2 gel pillows
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
Z-2192-2014 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedUnknown
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
Z-0601-2016 · View FDA record ↗ - EHOB, Inc.TerminatedUnknown
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and t
QC inspection observed that a portion of the lot may have been contaminated with blood.
Z-2640-2020 · View FDA record ↗
Registered firms
386 firms currently registered for this product code
Solventum Us Llc
Eagan, MN, US
Ansion Technology Limited
SHEUNG WANHONG KONG, HK
Sunrise Medical (us) Llc
FRESNO, CA, US
Hill-rom, Inc.
Batesville, IN, US
Henan Chaoya Medical Equipment Co., Ltd.
Zhengzhou Henan, CN
Sunrise Medical Tecnologias, S.a. De Cv
Tijuana Baja California, MX
Dongguan China Effort Healthcare Products Co., Ltd.
Dongguan City Guangdong, CN
Arthrex Chile Spa
Pudahuel Region Metropolitana, CL
Wear Tex S. De R.l. De C.v.
Torreon Coahuila, MX
Libertech Corporation
HWASEONG-SI Gyeonggi, KR
Paceline, Inc.
Matthews, NC, US
Posey, S. De R.l. De C.v.
Tijuana Baja California, MX
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Chs Usa Incorporated
PEACHTREE CITY, GA, US
Exel Inc. D/b/a Dhl Supply Chain (usa)
Southaven, MS, US
Shengzhou Kingbird Travel Products Co. Ltd
Shengzhou Zhejiang, CN
Variteks Ortopedi Sanayi A.s.
Catalca Istanbul, TR
Sunset Healthcare Solutions, Inc.
CHICAGO, IL, US
Prim, S.a.
Casarrubios del Monte Toledo, ES
Ningbo Chibanda Imp &exp Co, Ltd
Ningbo Zhejiang, CN
Kamex International S.a.s
Cajica Cundinamarca, CO
Medline Industries, Lp - Northfield
Northfield, IL, US
Barbaras Development, Inc.
Thousand Oaks, CA, US
Mehor Japan Co., Ltd
Osaka-shi, JP
Sterigenics U.s., Llc
Corona, CA, US
510(k) clearances
23 clearances for this product code
- Invictus Medical, Inc.May 1, 2015
K150243 · Invictus Medical GelShield
- Richard Hamer Assoc., Inc.Jul 31, 1995
K951325 · COMFEEL PLUS PRESSURE RELIEF DRESSING
- Medsurg Industries, Inc.Mar 28, 1994
K934731 · MEDSURG STERILE IMAGING PRODUCTS
- Abco Dealers, Inc.Mar 25, 1982
K820584 · DECUBICARE PADS & ACCESSORIES
- Fred Sammons, Inc.Sep 11, 1981
K812344 · HEEL OR ELBOW PROTECTOR
- Spenco Medical Corp.May 20, 1981
K811184 · SPENCO DERMAL PADS
- Scanlan Intl., Inc.Jan 15, 1981
K802829 · SCANLAN VASCU-STATT
- Current Technologies, Inc.Oct 10, 1980
K802185 · ARTERIAL BLOOD SAMPLING KIT