MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-08-20 for HUDSON BITE-GARD ORAL BITE BLOCK, INTL 41140 manufactured by Teleflex.
[4850302]
The complaint is reported as: the customer alleges that the pt bit through the bite guard after being inserted for approximately three hours. The pt was intubated but off sedation and restless.
Patient Sequence No: 1, Text Type: D, B5
[12327949]
A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. The lot number was not provided, therefore it is not possible to determine in which conditions this material was manufactured. A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. This customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident. According to the complaint description provided by the customer, "pt bit through bite guard after being inserted for approximately 3 hrs" this could have led to the damage reported by the customer. However current production was verified to identify any issue that can lead to the reported defect and no issues were found. If the device sample becomes available this investigation will be updated with eval results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00331 |
| MDR Report Key | 4062905 |
| Report Source | 01,06,07 |
| Date Received | 2014-08-20 |
| Date of Report | 2014-07-30 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-07-30 |
| Date Added to Maude | 2014-09-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer Street | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BITE-GARD ORAL BITE BLOCK, INTL |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2014-08-20 |
| Catalog Number | 41140 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RTP NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-20 |