MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2013-03-29 for HUDSON BITEGARD 1140 manufactured by Teleflex Medical.
[16049189]
The complaint was reported as: the complaint alleges that bite block broke while in the patient's mouth. The report indicates that the block was able to be removed safely. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[16504639]
Voluntary report number: (b)(4) (from maude event report). A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record (dhr) for the reported lot number was reviewed and no issues or discrepancies were found which could potentially relate to this complaint. The dhr shows that the product was assembled and inspected according to our specifications. The customer complaint cannot be confirmed due to the lack of the defective sample or a picture of it. In order to perform a proper investigation to determine a root cause for the defect reported the physical sample or a picture of the device is necessary. Root cause - unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2013-00099 |
| MDR Report Key | 3032773 |
| Report Source | 00,05,06 |
| Date Received | 2013-03-29 |
| Date of Report | 2013-03-14 |
| Date of Event | 2013-02-02 |
| Date Mfgr Received | 2013-03-14 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-04-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, CLINICAL SPEC. |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 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 BITEGARD |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2013-03-29 |
| Catalog Number | 1140 |
| Lot Number | 02C1200567 |
| Device Availability | Y |
| 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 | 2013-03-29 |