MAUDE Adverse Event Report: NEW PROKIN FULL BODY W/COMMODE MESH MED. 9153632097; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number R114

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

The dealer states that the patient alleges that the hole is fraying and the sling is causing a pressure sore and her wound doctor told her not to use the sling anymore.The dealer states that the patient made her aware a few weeks ago that she had to go to the wound doctor.

• Brand Name: FULL BODY W/COMMODE MESH MED. 9153632097
• Type of Device: SLING, OVERHEAD SUSPENSION, WHEELCHAIR
• Manufacturer (Section D): NEW PROKIN; zhongshan ; CH
• MDR Report Key: 5093596
• MDR Text Key: 26369093
• Report Number: 1531186-2015-01050
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 09/11/2015,09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R114
• 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: 09/11/2015
• Distributor Facility Aware Date: 09/09/2015
• Date Report to Manufacturer: 09/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention