MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-10 for RUBBER TOOTH PROTECTOR FOR MOUTH GAG manufactured by Unknown.
[10321]
Tonsillectomy performed on 2/3/94 using mouth protector became dislodged from gag but not noticed as missing. Not seen in child's mouth because it was clear. Apparently swallowed. Father of child reported that on 2/16/94, the child coughed or vomited up the 1" x 1/2" clear rubber tooth protector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16850 |
| MDR Report Key | 16850 |
| Date Received | 1994-04-10 |
| Date of Report | 1994-04-10 |
| Date of Event | 1994-02-03 |
| Date Facility Aware | 1994-04-07 |
| Report Date | 1994-04-10 |
| Date Reported to FDA | 1994-04-10 |
| Date Added to Maude | 1994-10-18 |
| 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 | RUBBER TOOTH PROTECTOR FOR MOUTH GAG |
| Generic Name | RUBBER TOOTH PROTECTOR FOR MOUTH GAG |
| Product Code | KBN |
| Date Received | 1994-04-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16783 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-10 |