MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 84IN W OPTION CVR; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number	2860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hospital is experiencing a general increase in pressure injuries on stryker surfaces.Attempts are being made to gather additional details from the user facility.
Event or Problem Description
It was reported that the hospital is experiencing a general increase in pressure injuries on stryker surfaces.
Additional Manufacturer Narrative
A stryker qae, a stryker engineering manager for customer quality, and a stryker sales account manager met with the somc nursing manager to discuss the alleged issue.Specific pressure injury instances from somc are captured within mfr report#: 0001831750-2022-00263 and mfr report#: 0001831750-2022-00264.The somc nursing manager confirmed that no further information regarding specific instances or details of pressure injuries were available.Based on recent complaint investigations for specific isoflex lal surfaces from somc, a stryker qae determined that the alleged increase in pressure injuries at the account is likely not due to any component level defects of the product.There are many factors that contribute to pressure ulcer development including heat, moisture, pressure braden scale ratings, patient mobility, nursing monitoring, and rotation schedules.

• Brand Name: ISOFLEX LAL 84IN W OPTION CVR
• Common Device Name: 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: melissa millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13651521
• Report Number: 0001831750-2022-00259
• Device Sequence Number: 19462753
• Product Code: IKY
• UDI-Device Identifier: 07613327278507
• UDI-Public: 07613327278507
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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 Model Number: 2860
• Device Catalogue Number: 2860000019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown