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

Catalog Number 2860000000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It has been reported that there has been a general increase in pressure injuries at this account.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

The investigation is complete.Section h codes have been updated.It was confirmed that no specific incident or injury was alleged, and further injury information has not been provided.H3 other text : unable to determine specific device, not available for evaluation.

Event Description

It was reported that there has been a general increase in pressure injuries at this account.The surfaces were likely beyond their intended service life and had not been replaced at the recommended interval.No specific adverse event was reported.

• Brand Name: ISOFLEX LAL 2860
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16477519
• MDR Text Key: 310594988
• Report Number: 0001831750-2023-00303
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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: 2860000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 03/28/2023
• 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