MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, FLOTATION THERAPY, POWERED

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

The account could not provide the serial number of the surface as they had only recorded the serial number of the bed at the time of the reported event.However, no product malfunction is alleged.The serial number of the mattress was not recorded.

Event Description

It was reported the patient developed a deep tissue injury while on the mattress.The patient had previously been found at their home, unconscious on their couch for an unknown amount of time.The pressure injury alleged developed shortly after admission, and the director of the icu reported they do not believe the stryker mattress caused or contributed to the alleged event.The patient was treated with a silicone bandage.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, FLOTATION THERAPY, 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7434608
• MDR Text Key: 105635121
• Report Number: 0001831750-2018-00201
• Device Sequence Number: 1
• Product Code: IOQ
• 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
• Report Date: 04/16/2018

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: UNK_MED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/16/2018
• 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