MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860 AFTERMARKET; BED, FLOTATION THERAPY, POWERED

Catalog Number 2860000999

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

A representative from the user facility advised they do not believe the device caused or contributed to the patient's skin breakdown.No malfunction was alleged.

Event Description

It was reported that a patient had experienced a breakdown of the skin of the heel.No further information regarding the condition of the patient was reported.

• Brand Name: ISOFLEX LAL 2860 AFTERMARKET
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7697693
• MDR Text Key: 114287575
• Report Number: 0001831750-2018-00737
• 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
• Report Date: 07/18/2018

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: 2860000999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/18/2018
• 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): Required Intervention