MAUDE Adverse Event Report: UNKNOWN DIVIDED LEG SLING HDRST MED 9153632090; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number R100

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

Event Description

The dealer stated her customer alleges the sling was starting to rip/fray.

• Brand Name: DIVIDED LEG SLING HDRST MED 9153632090
• Type of Device: SLING, OVERHEAD SUSPENSION, WHEELCHAIR
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5873068
• MDR Text Key: 52016406
• Report Number: 1525712-2016-02578
• Device Sequence Number: 1
• Product Code: INE
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• 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