MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2009-07-31 for BITE GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[1176945]
The event is described: during removal of bite block, the handle disconnected from the block. It was reported that the patient was biting on the endotracheal tube. No patient injury or intervention reported.
Patient Sequence No: 1, Text Type: D, B5
[8369397]
The results of the investigation are not available at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2009-00051 |
| MDR Report Key | 1485793 |
| Report Source | 01,06,08 |
| Date Received | 2009-07-31 |
| Date of Report | 2006-07-16 |
| Date of Event | 2009-06-23 |
| Date Mfgr Received | 2009-07-16 |
| Date Added to Maude | 2009-11-09 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE GARD MOLAR BITE BLOCK |
| Generic Name | BITE GARD |
| Product Code | JXL |
| Date Received | 2009-07-31 |
| 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 | 2009-07-31 |