Cover, Mattress (medical Purposes)
General Hospital · 21 CFR 880.6190
Recent MDR events
120 adverse event reports on file
- WALGREENS BED PROTECTORApr 21, 2026MalfunctionMedline Industries, Lp1417592-2026-00322
- DRIVE DEVILBISS HEALTHCARE APP SYS,DLX,VARIABLE PRESSUREJan 14, 2026InjuryGrand Healthcare Co. Ltd2438477-2026-00001
- COVER, MATTRESS (MEDICAL PURPOSES)Jan 6, 2025MalfunctionSeg-max/derby Industries.MW5164315
- COVER, MATTRESS (MEDICAL PURPOSES)Jan 6, 2025MalfunctionSeg-max/derby Industries.MW5164316
- COVER, MATTRESS (MEDICAL PURPOSES)Oct 21, 2024MalfunctionUnkMW5161264
- NO DEVICEOct 14, 2024InjuryAllergan (costa Rica)9617229-2024-22569
- GURNEY MATTRESS COVEROct 9, 2024MalfunctionStryker MedicalMW5160934
- SOFTFORM PREMIERSep 27, 2024InjuryInvacare Uk3007582653-2024-00001
- COVER, MATTRESS ( MEDICAL PURPOSES)Aug 12, 2023InjuryCompassMW5130594
- MATTRESS, AIR FLOTATION, ALTERNATING PRESSUREAug 12, 2023InjuryCaremed; UnknownMW5132635
Event type breakdown
Recalls
3 recall events for this product code
- Primus Medical LLCTerminatedSep 9, 2014
Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced Mattress, Prime Care Transcend Advanced Perimeter Matt
The firm found that the top cover of the mattresses were delaminating.
Z-2596-2014 · View FDA record ↗ - Invacare CorporationTerminatedSep 12, 2010
CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds.
In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Beds, when used with Invacare bed rails. Affected bed packages are BED24IVC, BED25IVC, BED24CA, and BED25CA. The mattresses when used in combination with the IVC a
Z-2402-2010 · View FDA record ↗ - Invacare CorporationTerminatedSep 12, 2010
Mattress Model 5185 and 5185XL.
In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric a
Z-2403-2010 · View FDA record ↗
Registered firms
215 firms currently registered for this product code
Medtecs International Corporation Limited
City of Hamilton, BM
Foam Craft
Fullerton, CA, US
Yizur Ltd
Hong Kong, HK
Standard Textile Co., Inc.
Cincinnati, OH, US
Jiaxing Weimei Textile Co., Ltd
Jiaxing City Zhejiang, CN
Gri Medical & Electronic Technology Co., Ltd.
JIAXING Zhejiang, CN
Walt Technology Group Co., Ltd.
Haining Zhejiang, CN
Valentine Intl. Ltd.
HSICHIH CITY, TAIPEI HSIEN, TW
Ningbo First Import & Export Co., Ltd.
NINGBO Zhejiang, CN
Care Line, Inc.
GREENBRIER, TN, US
Anqing Kangmingna Packaging Co.,ltd
Anqing Anhui, CN
Ningbo Kanghong Electrical Appliance Co., Ltd
Cixi Zhejiang, CN
Poliuretanos, S.a. De C.v.
Toluca Mexico, MX
P.c.p. Champion
RIPLEY, OH, US
Jiangyin Huashi Medical Equipment Co.,ltd
Jiangyin City Jiangsu, CN
Dalian Rongbang Medical Healthy Devices Co Ltd
Dalian Liaoning, CN
Alpha Tekniko
Lake Zurich, IL, US
Roho, Inc.
Belleville, IL, US
Honghu Danielle Sanitary Material Co., Ltd.
Honghu City Hubei, CN
Ready Set Import
Beverly Hills, CA, US
Welkong Sports Industrial Co.,ltd
Dongguan city Guangdong, CN
Hubei Haixin Protective Products Group Co.,ltd
Songzi City Hubei, CN
Alimed, Llc
DEDHAM, MA, US
Amd Medicom Inc.
Pointe-Claire, Montreal Quebec, CA
Ningbo Castle Medical Import & Export Co.,ltd
Ningbo Zhejiang, CN
510(k) clearances
14 clearances for this product code
- Precision Fabrics Group, Inc.Jun 20, 2016
K152884 · DermaTherapy Bed Linens
- Precision Fabrics Group, Inc.Jan 25, 2007
K061242 · DERMATHERAPY, MODEL 22216
- Demite LimitedDec 10, 2001
K001003 · Z-NET
- Allergy DirectNov 8, 1999
K992702 · EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- W. L. Gore & Associates, Inc.Feb 25, 1994
K940327 · INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
- Paladin Medical, Inc.Nov 29, 1993
K935220 · CORE PREVENT MATTRESS MODIFICATION
- Perfect Fit Industries, Inc.Feb 10, 1993
K924807 · REUSABLE INCONTIENT UNDERPAD
- Perfect Fit Industries, Inc.Jan 29, 1993
K924477 · WIPEABLE PILLOW