MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-22 for FULL BODY W/COMMODE MESH XLRG 9153632099 R116 manufactured by New Prokin.
[36645427]
The facility rep states the sling came apart where the handle attaches to the sling. The facility rep states there was a consumer in the sling, and the end user fell out of the sling and was injured. The rep states the end user had a laceration to his right shoulder and had to receive stitches at the er. Update from 01/15/2016 added by consumer affairs: sling has been set up to return and has been replaced. No lot number on the tag available. End user received medical treatment and is in good condition. No further information will be provided due to hipaa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2016-00002 |
| MDR Report Key | 5385759 |
| Date Received | 2016-01-22 |
| Date of Report | 2016-01-12 |
| Date Facility Aware | 2016-01-12 |
| Report Date | 2016-01-21 |
| Date Reported to FDA | 2016-01-21 |
| Date Reported to Mfgr | 2016-01-21 |
| Date Added to Maude | 2016-01-22 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FULL BODY W/COMMODE MESH XLRG 9153632099 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | INE |
| Date Received | 2016-01-22 |
| Model Number | R116 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW PROKIN |
| Manufacturer Address | ZHONGSHAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-01-22 |