MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for FULL BODY SLING SOLID MEDIUM 9153632095 R112 manufactured by New Prokin.
[33243464]
Customer alleged that the patient fell out of the sling. He stated that there is nothing wrong with the sling. He stated he does not believe the caregiver had the patient in the sling correctly. The rep went into the facility and did an in-service and inspected the lift and all the slings and found no issue with any of the slings or lifts. Rep alleged that the patient is in the hospital. Rep stated that there is head trauma. No further information is known at this time. Update from 12/09/2015 added by consumer affairs: no end user information provided due to hipaa. No further information provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2015-01057 |
| MDR Report Key | 5284842 |
| Date Received | 2015-12-10 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-12-03 |
| Date Facility Aware | 2015-12-04 |
| Report Date | 2015-12-09 |
| Date Reported to FDA | 2015-12-09 |
| Date Reported to Mfgr | 2015-12-09 |
| Date Added to Maude | 2015-12-10 |
| 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 | 0 |
| Brand Name | FULL BODY SLING SOLID MEDIUM 9153632095 |
| Generic Name | SLING, OVERHEAD SUSPENSION, WHEELCHAIR |
| Product Code | INE |
| Date Received | 2015-12-10 |
| Model Number | R112 |
| 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 | 2015-12-10 |