MAUDE Adverse Event Report: H FINE & SONS LTD 4PT-1PC,POSSTRAP SLNG; PATIENT SLING

Model Number 70051

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

The sling was thrown away by the facility.

Event Description

It was reported to the manufacturer by the end user, per the end user, resident was being moved from a reclining bariatric chair to the bed.The upper strap broke in the middle of the strap and the lower strap broke where it's attached to the sling.The resident slid out of the sling feet first and she fell to the floor.She landed on the hip that fractured.The resident was in the sitting position prior to the fall.The resident was taken to the local er and has sustained a fractures left hip.Upon speaking with the facility about the incident and product involved, the facility stated that they had trashed the sling involved and did not take any pictures of the failure.(b)(4).

• Brand Name: 4PT-1PC,POSSTRAP SLNG
• Type of Device: PATIENT SLING
• Manufacturer (Section D): H FINE & SONS LTD; victoria house; 93 manor farm road; wembly middlesex, london HAO 1 XB; UK HAO 1XB
• Manufacturer (Section G): H FINE & SONS LTD; victoria house; 93 manor farm road; wembly middlesex, london HAO 1 XB; UK HAO 1XB
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6073170
• MDR Text Key: 59010586
• Report Number: 3009402404-2016-00040
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70051
• Device Catalogue Number: 70051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR