MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CMFRTGL W/B, W/FB 84X35X7 INT; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2850000016

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 08/04/2021

Event Type  Injury  

Event Description

It was reported that the hospital has had a general increase in pressure ulcers while using the mattress.The most common type of pressure ulcer (decubitus) is in the sacrum area where the gel core of the mattress is located.Further information has not been provided in regard to injury treatment or specific events.

Manufacturer Narrative

The customer has stated that they do not consider the surface to have malfunctioned to cause this increase in injuries and did not request any further follow up regarding this situation.No serial numbers were provided, and no product malfunctions or defects were alleged.Additionally, no specific instances or details of pressure injuries were reported in association with the product, but rather a general increase in pressure injuries.H3 other text : device not accessible for evaluation.

Event Description

It was reported that the hospital has had a general increase in pressure ulcers while using the mattress.The most common type of pressure ulcer (decubitus) is in the sacrum area where the gel core of the mattress is located.Further information has not been provided in regard to injury treatment or specific events.

• Brand Name: CMFRTGL W/B, W/FB 84X35X7 INT
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12297287
• MDR Text Key: 265777795
• Report Number: 0001831750-2021-01295
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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 Catalogue Number: 2850000016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 11/08/2021
• 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