MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,08 report with the FDA on 2010-06-02 for BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[1399100]
The event was reported as: device broke during use. The green part of the device was left in back of patient's mouth when it broke. Broken part retrieved. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8620957]
The device sample was not returned for evaluation at the time of this report. The results of the investigation are not available at the time of this report. A follow-up report will be sent when investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2010-00071 |
| MDR Report Key | 1722253 |
| Report Source | 01,04,08 |
| Date Received | 2010-06-02 |
| Date of Report | 2010-05-06 |
| Date of Event | 2010-04-26 |
| Date Mfgr Received | 2010-05-06 |
| Date Added to Maude | 2010-11-18 |
| 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, MANAGER |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE-GARD MOLAR BITE BLOCK |
| Generic Name | BITE-GARD MOLAR BITE BLOCK |
| Product Code | JXL |
| Date Received | 2010-06-02 |
| Model Number | NA |
| Catalog Number | 1140 |
| Lot Number | 02G0900707 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| 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 | 2010-06-02 |