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 Tissue Breakdown (2681)

Event Date 11/03/2018

Event Type  Injury  

Event Description

It was reported a patient's skin broke down while on the mattress.

Manufacturer Narrative

It was reported to the account manager that the account placed an ehob overlay underneath the patient, on top of the mattress, following the discovery of the injury.The patient was discharged the next day and the account did not speak of any medical treatment for the alleged injury.A review of photos of the reported injury by a stryker clinical nurse consultant, found that she believed the patient had shown discoloration in the shape of the gel that resembles reactive hyperemia.No malfunction or defect was alleged.Serial number of the unit was not recorded.

Event Description

It was reported a patient's skin broke down while on the mattress.

• 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: 8126800
• MDR Text Key: 129147244
• Report Number: 0001831750-2018-01447
• 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,Followup
• Report Date: 02/01/2019

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 02/01/2019
• 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