MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-23 for JOERNS TRAPEZE N529 * manufactured by Joerns Healthcare, Inc..
[4582935]
The trapeze handle has poor paint that chips off and falls on the patient's face when they are attempting to use it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3922767 |
| MDR Report Key | 3922767 |
| Date Received | 2014-06-23 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-23 |
| Report Date | 2014-06-23 |
| Date Reported to FDA | 2014-06-23 |
| Date Reported to Mfgr | 2014-07-09 |
| Date Added to Maude | 2014-07-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOERNS TRAPEZE |
| Generic Name | DEVICE, TRANSFER, PATIENT, MANUAL |
| Product Code | FMR |
| Date Received | 2014-06-23 |
| Model Number | N529 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOERNS HEALTHCARE, INC. |
| Manufacturer Address | 2100 DESIGN ROAD ARLINGTON TX 76014 US 76014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-23 |