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HomeThomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft › ThevoRelief FR 220 lbs, Hospital size 36x79", jersey ThevoRelief FR 220 Ibs, Twi

ThevoRelief FR 220 lbs, Hospital size 36x79", jersey ThevoRelief FR 220 Ibs, Twi

Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft · Model 9800694040004 · UDI-DI 04034089066943

IKY
8
510(k) clearances
1,577
Adverse events (35 deaths)
11
Recalls
157
Facilities

Recalls

DateFirmReason
2021-05-12Stryker Medical Division of Stryker CorporationMedical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-05-12Stryker Medical Division of Stryker CorporationMedical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-05-12Stryker Medical Division of Stryker CorporationMedical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2021-04-19EHOB, Inc.Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
2020-08-12Stryker Medical Division of Stryker CorporationConnector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients exper
2020-01-19EHOB, Inc.Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a subset of the lot- contro
2018-05-03Joerns HealthcareJoerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresse
2018-05-03Joerns HealthcareJoerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresse
2014-09-01Arjo Hospital Equipment ABThe firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
2011-04-29Stryker Medical Division of Stryker CorporationAffected mattresses may not conform to federal flammability standards.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.