MAUDE Adverse Event Report: UNKNOWN FULL BODY SLING MESH LARGE W/HEAD SUPPORT 9153646789; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number R111

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

The straps on this sling ripped while in use but no one was hurt.It was confirmed with the customer that they are following all of the proper washing techniques - no bleach or hot water, hung to dry.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the straps were ripped off the sling, which confirmed the original complaint issue.However, the underlying cause could not be determined.

Event Description

The straps on this sling ripped while in use but no one was hurt.It was confirmed with the customer that they are following all of the proper washing techniques - no bleach or hot water, hung to dry.

• Brand Name: FULL BODY SLING MESH LARGE W/HEAD SUPPORT 9153646789
• 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: 5113008
• MDR Text Key: 27180990
• Report Number: 1525712-2015-04694
• 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
• Remedial Action: Replace
• Report Date: 09/30/2015

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: R111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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