MAUDE Adverse Event Report: NEW PROKIN FULL BODY SLING SOLID MEDIUM 9153632095; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number R112

Device Problem Fracture (1260)

Patient Problem Contusion (1787)

Event Type  Injury  

Event Description

Customer states the strap on item r112 directly above the patients head, ripped, the patient fell out of the sling, hit their head causing a head contusion.Ct scan was negative.No additional information provided.

• Brand Name: FULL BODY SLING SOLID MEDIUM 9153632095
• Type of Device: SLING, OVERHEAD SUSPENSION, WHEELCHAIR
• Manufacturer (Section D): NEW PROKIN; zhongshan ; CH
• MDR Report Key: 5390159
• MDR Text Key: 36892898
• Report Number: 1531186-2016-00003
• 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
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 01/23/2016,01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R112
• 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: 01/23/2016
• Distributor Facility Aware Date: 01/12/2016
• Date Report to Manufacturer: 01/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization