MAUDE Adverse Event Report: PROACTIVE MEDICAL PRODUCTS PROACTIVE MEDICAL DEVICE; FULL BODY MESH SLING

Lot Number 3011

Device Problems Break (1069); Defective Device (2588)

Patient Problem Hip Fracture (2349)

Event Date 11/24/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, at approx 7:08 pm, staff were using a mechanical list to transfer a resident from wheel chair to her bed.When the sling holding the resident ripped at the support loop causing resident to slide out of the sling onto the floor , causing injury to the resident and hospitalization.

• Brand Name: PROACTIVE MEDICAL DEVICE
• Type of Device: FULL BODY MESH SLING
• Manufacturer (Section D): PROACTIVE MEDICAL PRODUCTS; 270 washington st.; mt. vernon NY 10553
• MDR Report Key: 6219416
• MDR Text Key: 63814361
• Report Number: 6219416
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016,12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2016
• Distributor Facility Aware Date: 11/24/2016
• Device Age: 3 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/15/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 68