MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-07-19 for MOUTH GAG - DAVID DOUBLE BITE LT N7451 manufactured by Bausch & Lomb, Inc..
[2060251]
User facility report # (b)(4) was received on (b)(4), 2011 stating: "mouth gag broke during tonsil and adenoids removal. The tooth guard broke off from the horseshoe (metal to metal). The pt had to have unnecessary stitches in the mouth. Tonsil and adenoid removal was intended and complete; however, unnecessary stitches in pt's mouth due to instrument breakage. " pt had no permanent injury, and the user facility anticipates no problems.
Patient Sequence No: 1, Text Type: D, B5
[9212450]
The device has not been received for eval at this time. A supplemental report will be filed should the device become available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2011-00083 |
| MDR Report Key | 2194694 |
| Report Source | 00,06 |
| Date Received | 2011-07-19 |
| Date of Report | 2011-06-23 |
| Date of Event | 2011-05-31 |
| Report Date | 2011-05-01 |
| Date Reported to FDA | 2011-05-01 |
| Date Reported to Mfgr | 2011-06-21 |
| Date Mfgr Received | 2011-06-23 |
| Date Added to Maude | 2011-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SHARON TRELFORD, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE, STE. 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | 3365 TREE CT., INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122669 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 6694 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOUTH GAG - DAVID DOUBLE BITE LT |
| Product Code | KBN |
| Date Received | 2011-07-19 |
| Model Number | N7451 |
| Catalog Number | N7451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-19 |