MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-27 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[5758635]
The customer alleges that during removal of the bitegard, the handle broke off inside the patient's mouth. The gard remained in the patient's mouth for 3 days until it was removed. Intervention-the patient had to be re-intubated because the patient was obstructing. No patient injury reported. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13034091]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided. A device history record review could not be conducted since the lot number was not provided. The customer complaint cannot be confirmed due to the lack of sample and since no lot number was provided for investigation. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time. If the sample becomes available at this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00107 |
| MDR Report Key | 4651072 |
| Report Source | 06 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-02-27 |
| Date Mfgr Received | 2015-03-06 |
| Date Added to Maude | 2015-05-13 |
| 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 | MARGIE BURTON, RN. REG. AFFAIRS |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD. |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BITE-GARD MOLAR BITE BLOCK |
| Product Code | JXL |
| Date Received | 2015-03-27 |
| Catalog Number | 1140 |
| 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 | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-27 |