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

Catalog Number UNK_MED

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Event Description

It was reported that a patient received an unstageable pressure injury after staying on an isoflex gel mattress.Attempts are being made to gather more details regarding the injury from the user facility.

Manufacturer Narrative

It was originally reported that a patient received a pressure injury.Upon further communication with the user, it was reported that a pressure injury did not occur on this device.

Event Description

It was originally reported that a patient received a pressure injury.Upon further communication with the user, it was reported that a pressure injury did not occur on this device.

• 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
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13671284
• MDR Text Key: 286606110
• Report Number: 0001831750-2022-00262
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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: 02/18/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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