MAUDE Adverse Event Report: H FINE & SONS LTD ONE PIECE CLASIC SLING; PATIENT SLING

Model Number 70051

Device Problems Material Separation (1562); Device Handling Problem (3265)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 12/30/2014

Event Type  Injury  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility the resident was being transferred from the bed to a shower stretcher.The sling strap on the resident's right side broke.The resident fell out of the sling, hit her head on an obt table and landed on her right side on the floor.The resident sustained a laceration to the head above the right ear.The resident was transported to the emergency room for eval and closure of the head laceration with steri strips.(b)(4).

Manufacturer Narrative

• Brand Name: ONE PIECE CLASIC SLING
• Type of Device: PATIENT SLING
• Manufacturer (Section D): H FINE & SONS LTD; london ; UK
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4428053
• MDR Text Key: 5371284
• Report Number: 3009402404-2015-00002
• 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
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2015
• Distributor Facility Aware Date: 12/30/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/09/2015
• Date Manufacturer Received: 01/07/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 111