MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860 AFTERMARKET; MATTRESS, FLOATATION THERAPY, NON-POWERED

Catalog Number 2860000999

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that the instance of pressure injuries has increased by 50% in the last 3 months due to the isoflex mattress.Further information regarding injury and treatment details have not yet been provided.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

The investigation is complete.Section h codes have been updated to reflect investigation findings.

Event Description

It was reported that there has been a 50% increase in pressure injuries in the last 3 months while using isoflex mattresses.The customer was unable to identify specific serial numbers that these pressure injuries occurred on.There are a number of different factors that contribute to pressure injuries, such as nutrition, skin condition, moisture and pressure injury treatment protocol.Given the clinical factors that are not within stryker's control and the lack of an alleged defect or malfunction, it was determined that the surface was likely operating as intended and that there were most likely no defects with the isoflex surface that would have potentially caused or contributed to the alleged pressure injuries.

• Brand Name: ISOFLEX LAL 2860 AFTERMARKET
• Type of Device: MATTRESS, FLOATATION 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12853038
• MDR Text Key: 281089712
• Report Number: 0001831750-2021-01633
• 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
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

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 Catalogue Number: 2860000999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other