MAUDE Adverse Event Report: NEW PROKIN FULL BODY SLING MESH MEDIUM 9153632093; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number R110

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It has been reported by a provider that a r110 sling is ripping at the seams.

• Brand Name: FULL BODY SLING MESH MEDIUM 9153632093
• Type of Device: SLING, OVERHEAD SUSPENSION, WHEELCHAIR
• Manufacturer (Section D): NEW PROKIN; zhongshan ; CH
• MDR Report Key: 4353103
• MDR Text Key: 5141762
• Report Number: 1531186-2014-06715
• Device Sequence Number: 1
• Product Code: INE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/22/2014,11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2014
• Distributor Facility Aware Date: 11/10/2014
• Date Report to Manufacturer: 12/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability