MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-11-18 for BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[21610331]
The event was reported as: the green plastic end became dislodged from the white plastic arm. It was retrieved from the pt's pharynx using a magill forceps. This report is the second of two separate incidents reported. No pt injury reported. No further info available.
Patient Sequence No: 1, Text Type: D, B5
[21744975]
Device has been sent to the mfr, but investigation report is not available yet. Investigation is ongoing, and a follow up report will be sent as soon as is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2008-00069 |
| MDR Report Key | 1235742 |
| Report Source | 08 |
| Date Received | 2008-11-18 |
| Date of Report | 2008-10-29 |
| Date Mfgr Received | 2008-10-29 |
| 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, MANAGER |
| Manufacturer Street | 4024 STIRRUP CREEK DR. |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL-NUEVO LAREDO |
| 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 |
| Product Code | JXL |
| Date Received | 2008-11-18 |
| Returned To Mfg | 2008-10-29 |
| Catalog Number | 1140 |
| Lot Number | 3007920407 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-18 |