MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-14 for MEDCARE PT MOVING SLING RFLO-0023, RFLO-0043, RBAR-0002 manufactured by Medcare.
[70268356]
In (b)(6) we noticed issues with the integrity of our pt, moving slings. We pulled approx 59 of them from service and called the company to get replacements. Due to shrinkage during laundering the fabric near the end pieces/tabs thinned and the fabric became weak. We have a photo. Main issue is that the fabric in these safe pt moving slings wears out after several washings, heat of dryer and use of bleach which is needed to properly clean them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068462 |
| MDR Report Key | 6409089 |
| Date Received | 2017-03-14 |
| Date of Report | 2017-03-14 |
| Date Added to Maude | 2017-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 HEALTH CARE PROFESSIONAL |
| 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 | MEDCARE PT MOVING SLING |
| Generic Name | MEDCARE PT MOVING SLING |
| Product Code | ILI |
| Date Received | 2017-03-14 |
| Model Number | RFLO-0023, RFLO-0043, RBAR-0002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCARE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-14 |