MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-12-05 for BITE-GUARD (MOLAR) 1140 manufactured by Teleflex Medical.
[1012378]
Incident reported as: the device broke while in use on a patient. Parts were not consumed in body. No patient injury or intervention reported.
Patient Sequence No: 1, Text Type: D, B5
[8130947]
Customer identified two lot numbers that they had and were uncertain which lot number was utilized on patient. Add'l lot number - 35079/24107. Device sample not available for eval. Investigation results not available at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2008-00076 |
| MDR Report Key | 1257715 |
| Report Source | 08 |
| Date Received | 2008-12-05 |
| Date of Report | 2008-11-25 |
| Date Mfgr Received | 2008-11-25 |
| Date Added to Maude | 2009-11-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MANAGER |
| Manufacturer Street | 4024 STIRRUP CREEK DRIVE |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| 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 GARD |
| Product Code | JXL |
| Date Received | 2008-12-05 |
| Model Number | NA |
| Catalog Number | 1140 |
| Lot Number | 02K070 / 01465 |
| ID Number | NA |
| Operator | OTHER |
| 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 | 2008-12-05 |