MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for COVIDIEN DYNH51865A manufactured by Covidien.
[59884664]
Doctor place light glove at the start of surgery and the lights were not moved again until surgery was finished. Tech notice split in the light glove when cleaning the room. Medline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065962 |
| MDR Report Key | 6098640 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-10-28 |
| Date Added to Maude | 2016-11-14 |
| 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 | RISK MANAGER |
| 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 | COVIDIEN |
| Generic Name | LIGHT GLOVE |
| Product Code | LYU |
| Date Received | 2016-11-09 |
| Model Number | DYNH51865A |
| Lot Number | 31140208 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-09 |