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

Catalog Number UNK_MED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Pressure Sores (2326)

Event Date 06/04/2020

Event Type  Injury  

Event Description

It was reported that a patient developed a pressure injury while laying on a isoflex mattress.It was further reported that there was a blanket between the patient and the mattress, and it is unknown which device caused the pressure injury.No information has been provided regarding the severity or treatment of the injury.Attempts have been made to reach the customer for more information, however they have not responded to these attempts.

Manufacturer Narrative

Investigation is complete.

Event Description

It was reported that a patient developed a pressure injury while laying on a isoflex mattress.No information has been provided regarding the severity or treatment of the injury.Attempts have been made to reach the customer for more information, however they have not responded to these attempts.Additionally, a stryker senior staff medical science liaison was consulted and it was identified that with the very limited information we have, this would be classified as a temporary/minor injury.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10211528
• MDR Text Key: 196956348
• Report Number: 0001831750-2020-00638
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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: 06/04/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other