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

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

User facility could not locate device for evaluation.

Event Description

The user facility reported there were 2 areas of suspected deep tissue injury to the patient's buttocks.

Manufacturer Narrative

Section d has been updated to indicate the device is an unknown surface.No further information was provided regarding the injury to the patient despite multiple attempts to gather more.

Event Description

The user facility reported there were 2 areas of suspected deep tissue injury to the patient's buttocks.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8235236
• MDR Text Key: 132764392
• Report Number: 0001831750-2019-00004
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 07613327169232
• UDI-Public: 07613327169232
• 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: 04/12/2019

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: 12/11/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2011
• 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