MAUDE Adverse Event Report: HANDICARE USA INC. DELUXE SUPPORT SPACER SLING - MEDIUM; LIFTING SLING

Model Number 8H4400

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Fall (1848)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

When lifting a user from a shower chair to his bed, a leg strap came off the sling.The user fell approximately 10 - 30 cm back into the chair and was uninjured.

Manufacturer Narrative

Additional manufacturer narrative: the sling was returned and investigated.It is not possible to determine a root cause.Despite static load test performed in various misuse scenarios, the failure was not able to be recreated.This testing, in addition to the 1.5 x safe working load standard testing, demonstrates that the failure is not caused by an overload.Complaints will be monitored to evaluate if corrective action is required in the future.

• Brand Name: DELUXE SUPPORT SPACER SLING - MEDIUM
• Type of Device: LIFTING SLING
• Manufacturer (Section D): HANDICARE USA INC.; 10888 metro ct.; maryland heights, mo
• MDR Report Key: 10332935
• MDR Text Key: 202036672
• Report Number: 3007802293-2020-00013
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8H4400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 82