MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-07 for GEN 4 CALL LIGHT manufactured by Curbell Medical.
[4993274]
Call light pendant failed -- sent back to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039072 |
| MDR Report Key | 4253560 |
| Date Received | 2014-11-07 |
| Date of Report | 2014-11-07 |
| Date of Event | 2014-11-05 |
| Date Added to Maude | 2014-11-18 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEN 4 CALL LIGHT |
| Generic Name | CALL LIGHT |
| Product Code | ILQ |
| Date Received | 2014-11-07 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 6899+10 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CURBELL MEDICAL |
| Manufacturer Address | ORCHARD PARK NY 14127 US 14127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-07 |