MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-26 for FULL BODY SLING SOLID MEDIUM 9153632095 R112 manufactured by New Prokin.
[36892898]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2016-00003 |
| MDR Report Key | 5390159 |
| Date Received | 2016-01-26 |
| Date of Report | 2016-01-12 |
| Date Facility Aware | 2016-01-12 |
| Report Date | 2016-01-23 |
| Date Reported to FDA | 2016-01-23 |
| Date Reported to Mfgr | 2016-01-23 |
| Date Added to Maude | 2016-01-26 |
| 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 | 0 |
| Brand Name | FULL BODY SLING SOLID MEDIUM 9153632095 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | INE |
| Date Received | 2016-01-26 |
| Model Number | R112 |
| 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 | 2016-01-26 |