MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-09 for BITE-GUARD MOLAR 1140 manufactured by Teleflex Medical.
[1152441]
The event description is reported as: a handle broke off from the part that goes between the pt's teeth. This alleged event happened when the crna was trying to remove the device with the pt firmly biting down. The broken piece was retrieved from the pt. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8310275]
The customer states that the actual device used in the reported incident is not available for eval. However, customer states, they may send a sample device with the reported catalog number that they have in their facility. The results of the investigation are not available at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2009-00037 |
| MDR Report Key | 1475974 |
| Report Source | 05,06 |
| Date Received | 2009-07-09 |
| Date of Report | 2009-06-02 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2009-10-30 |
| 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 | ANGELA BROWN, MGR |
| Manufacturer Street | 4024 STIRRUP CREEK DR. |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MED |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE-GUARD MOLAR |
| Generic Name | BITE-GUARD |
| Product Code | JXL |
| Date Received | 2009-07-09 |
| Model Number | NA |
| Catalog Number | 1140 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-09 |