MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-05-03 for HUDSON RCI BITE GUARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[17555523]
The event is reported as: complaint alleges that external portion of the bite guard separated from the piece that sits internally between the patient's molars which was causing difficulty to remove the bite guard from the patient's mouth. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17655399]
No sample or lot number is available for the manufacturer to investigate. Conclusions: other - no conclusion can be established based on lack of sample. No corrective action was taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00192 |
| MDR Report Key | 2102869 |
| Report Source | 06,07 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-04-08 |
| Date Mfgr Received | 2011-04-21 |
| Date Added to Maude | 2012-03-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE BURKLE, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON RCI BITE GUARD MOLAR BITE BLOCK |
| Generic Name | BITE GUARD MOLAR |
| Product Code | BRW |
| Date Received | 2011-05-03 |
| Model Number | NA |
| Catalog Number | 1140 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-03 |