MAUDE Adverse Event Report: HANDICARE AB RETURN BELT, WIPEABLE; SAFETY, SUPPORT BELT

Model Number 6134

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

A handicare representative was demonstrating a sit to stand device equipped with an optional, wipeable safety belt.While demonstrating the function of the safety belt, the strap that secures the belt to the device frame, ripped at the seam.No injuries were reported as a result of the incident.Handicare have received another complaint of a similar nature and therefore has made the decision to initiate a voluntary recall of the wipeable return belt.

• Brand Name: RETURN BELT, WIPEABLE
• Type of Device: SAFETY, SUPPORT BELT
• Manufacturer (Section D): HANDICARE AB; maskinvagen 17; lulea ; SW
• MDR Report Key: 4652604
• MDR Text Key: 5605156
• Report Number: 3005536958-2015-00001
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2015,02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6134
• Device Catalogue Number: 6135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2015
• Distributor Facility Aware Date: 02/06/2015
• Event Location: Other
• Date Report to Manufacturer: 03/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1