MAUDE Adverse Event Report: UNKNOWN DIVIDED LEG SLING HDRST. LRG. 9153632091; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number UNKNOWN

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Dealer stated that the r101 divided leg sling for an unknown lift is coming apart at the seams.

• Brand Name: DIVIDED LEG SLING HDRST. LRG. 9153632091
• Type of Device: SLING, OVERHEAD SUSPENSION, WHEELCHAIR
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4381517
• MDR Text Key: 20127693
• Report Number: 1525712-2014-08365
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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