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); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  Injury  

Event Description

It was reported through a survey study that a patient acquired a pressure injury upon placement and during treatment on the surface.It was reported that the patient was chronically ill with emergent admission to the icu.

Event Description

It was reported through a survey study that a patient acquired a pressure injury upon placement and during treatment on the surface.It was reported that the patient was chronically ill with emergent admission to the icu.

Manufacturer Narrative

The customer further reported that the surface did not contribute to the alleged stage i pressure injury, as the patient was already chronically ill upon admission to the icu.There were no discernable defects alleged with the product.Based on this information, it was determined that the injury should not attributed to the stryker product.This issue was resolved for the customer by confirming no further action was needed by stryker at this time.

• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17443135
• MDR Text Key: 320226298
• Report Number: 0001831750-2023-00972
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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?: No
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 11/02/2023
• 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