MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX 35X84X6 NYLON; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2800100010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Date 07/28/2015

Event Type  Injury  

Event Description

It was reported that there was a general increase in hapu (hospital-acquired pressure ulcer) occurrences on the isoflex mattresses.

• Brand Name: ISOFLEX 35X84X6 NYLON
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5114069
• MDR Text Key: 27129444
• Report Number: 0001831750-2015-00460
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2800100010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1