MAUDE Adverse Event Report: H FINE & SONS LTD FULL BACK SLING; PATIENT SLING

Model Number NA1068

Device Problems Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 02/03/2019

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, "resident was placed in red strip hoyer pad.The top white straps were used upper body and the blue straps were used on the lower legs, with straps crossed.Crca's raised resident up in hoyer, where everything looked good and appropriate.The crca's said that the resident did appear to be higher, looking as if she was sitting up in the hoyer pad, and then they noticed her slipping out of the pad.Resident then fell and hit the back of her head on the bottom of the bed frame." the resident sustained a laceration on left posterior calf, laceration to posterior scalp, bruise to right cheek and skin tear to right side of forehead.The resident was transported to the hospital for evaluation.A joerns representative visited the facility on 2/13/2019 to inspect the lift and sling involved.Upon discussing the incident, it was determined that the sling was used incorrectly on the resident.Complaint# (b)(4) was entered into our system.

• Brand Name: FULL BACK SLING
• Type of Device: PATIENT SLING
• Manufacturer (Section D): H FINE & SONS LTD; victoria house 93 manor farm r; wembly, middlesex HAO 1 XB; UK HAO 1XB
• Manufacturer (Section G): H FINE & SONS LTD; victoria house 93 manor farm r; wembly, middlesex HAO 1 XB; UK HAO 1XB
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 8345789
• MDR Text Key: 136351785
• Report Number: 3009402404-2019-00010
• 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: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA1068
• Device Catalogue Number: NA1068
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2019
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR
• Patient Weight: 86