MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number UNK_MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pressure Sores (2326); Insufficient Information (4580)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

It was reported that the patient developed a pressure injury while on the surface.Further information has not been provided.

Manufacturer Narrative

Upon further investigation into this event, it was identified that stryker does not manufacture the device.It was identified that this device is manufactured by hill-rom.The complaint information was sent to the manufacturer hill-rom.

Event Description

It was reported that the patient developed a pressure injury while on the surface.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16150670
• MDR Text Key: 307218851
• Report Number: 0001831750-2023-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/28/2023

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?: Yes
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 06/28/2023
• 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