MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-05 for STORZ SILICONE BIT LINER N7545 manufactured by Bausch & Lomb, Inc..
[2580198]
A report from the user facility reported "they were using the mouth gag with the (b)(4) bite liner to perform a tonsil and adenoidectomy on a (b)(6) female. After completing the procedure they noted one of the nipples that keeps the bite liner attached to the mouth gag was missing. They tried doing an x-ray to locate it as well as a laryngoscopy and could not find the missing piece. " additional info: they excavated after the surgery and then noticed the liner part was missing so they had to re-intubate the pt.
Patient Sequence No: 1, Text Type: D, B5
[9893743]
The device has not been received for evaluation 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 | 1920664-2012-00058 |
| MDR Report Key | 2526457 |
| Report Source | 06 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-03-07 |
| Date Mfgr Received | 2012-03-07 |
| Date Added to Maude | 2012-04-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON SPENCER, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE SUITE 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 | STORZ SILICONE BIT LINER |
| Generic Name | SILICONE BITE LINER |
| Product Code | KBN |
| Date Received | 2012-04-05 |
| Model Number | N7545 |
| Catalog Number | N7545 |
| 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 | 2012-04-05 |