MAUDE Adverse Event Report: UNKNOWN SLING UNIV HIGH SPACER LARGE 9153649442; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number UNKNOWN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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.User¿s manual review (1023891 rev.I, page 6) after each laundering (in accordance with instructions on the sling), inspect sling(s) for wear, tears, and loose stitching.Bleached, torn, cut, frayed, or broken slings are unsafe and could result in injury.Discard immediately.The product manufacturer is unknown.Unknown if sling is invacare or pro active.Invacare is one of the possible manufacturers so invacare has chosen to file the 3500a with the fda under the invacare cfn/fei.

Event Description

Caller is stating that the sling broke and he is investigating the facility.Caller has been told by the facility that the strap broke on the sling, it detached where it attaches.He also said they cannot find the sling at the facility.He knows the facility uses both invacare and pro active slings, not sure what sling was being used.He knows the sling was ordered in (b)(6) 2014 and failed (b)(6) 2015.

• Brand Name: SLING UNIV HIGH SPACER LARGE 9153649442
• 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: 5339990
• MDR Text Key: 35279039
• Report Number: 1525712-2015-05997
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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: 12/15/2015
• 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