MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-18 for UNK manufactured by Unk.
[181012]
Following adenotonsillectomy, pt was observed to have swollen, shiny upper lip and grayish discolorations on pt's lower lip. The bovie pad and mouth gag appeared unremarkable, and are undergoing biomed review, which is currently inconclusive. Pt was referred for allergy/immunology to rule out allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 290865 |
| MDR Report Key | 290865 |
| Date Received | 2000-08-18 |
| Date of Report | 2000-08-17 |
| Date of Event | 2000-08-08 |
| Date Facility Aware | 2000-08-09 |
| Report Date | 2000-08-17 |
| Date Reported to FDA | 2000-08-17 |
| Date Added to Maude | 2000-08-21 |
| 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 | 0 |
| 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 | UNK |
| Generic Name | BOVIE PAD |
| Product Code | JOS |
| Date Received | 2000-08-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 281509 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Brand Name | UNK |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 2000-08-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 281511 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-08-18 |