MAUDE Adverse Event Report: UNKNOWN FULL BODY SLING SOLID LARGE 9153632096; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number R113

Device Problems Device Reprocessing Problem (1091); Material Discolored (1170); Material Frayed (1262); Torn Material (3024)

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

Event Type  malfunction  

Event Description

The caller states that while lifting the patient, the strap on one side shredded and tore like paper.The caller states this almost caused the patient to be dropped.The caller believes the unit was bought in 2013.The caller states that they use an outside laundry service, and they have turned the slings to a pink color from the dark color, due to possible bleaching.No further information available.

• Brand Name: FULL BODY SLING SOLID LARGE 9153632096
• 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 44036 ; 8003336900
• MDR Report Key: 4420149
• MDR Text Key: 5376740
• Report Number: 1525712-2015-00349
• Device Sequence Number: 1
• Product Code: FNG
• 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: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/15/2015
• 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