MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-09 for FULL BODY W/COMMODE MESH XLRG 9153632099 R116 manufactured by New Prokin.
[46889510]
Customer alleges 2 staff members were using the sling to lift a patient and two straps on the same side of the sling broke off. Straps snapped on both sides which caused their patient to go to the ground. She had a scratch/abrasion on the back of her head that was slowly bleeding. She was taken to the hospital and she is still at the hospital and she was alert and responsive so they do not anticipate that it was a serious injury. No further info provided. Update from consumer affairs on 5/24/2016: facility states the end user had a cat scan done at the er and they were treated and released and sling is being replaced. No further information provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2016-00014 |
| MDR Report Key | 5708906 |
| Date Received | 2016-06-09 |
| Date of Report | 2016-05-20 |
| Report Date | 2016-05-25 |
| Date Reported to FDA | 2016-05-25 |
| Date Reported to Mfgr | 2016-05-25 |
| Date Added to Maude | 2016-06-09 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2016-06-09 |
| Model Number | R116 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-06-09 |