MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX 35X84 DARTEX W/FB; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2800000000

Device Problem Insufficient Information (3190)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 12/07/2017

Event Type  Injury  

Event Description

It was reported that a patient experienced pressure injuries while lying on an isoflex mattress.No specific defect was alleged with the product, and any possible medical intervention was not reported.

Manufacturer Narrative

Unit part number has been updated.It was confirmed that the patient had a stage 2 pressure injury in the coccyx region that progressed to a stage 3 injury, then to an unstageable injury, which was treated with allevyn dressing.It was further reported that the user did not believe that the surface caused or contributed to the injury, and upon evaluation the unit was found to be within specifications.

Event Description

It was reported that a patient experienced pressure injuries while lying on an isoflex mattress.No specific defect was alleged with the product, and any possible medical intervention was not reported.

• Brand Name: ISOFLEX 35X84 DARTEX W/FB
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7160137
• MDR Text Key: 96322226
• Report Number: 0001831750-2018-00010
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2800000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/12/2018
• 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