MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2010-06-04 for PILLING RING BLADE RIGHT #2 764PG 070330 manufactured by Teleflex Medical.
[1633316]
A medwatch was received for this device. The customer reports that the mouth gag was placed in the pt's mouth for a surgical procedure. The instrument snapped apart while still in the pt's mouth. The pt's mouth closed. The doctor examined the pt's teeth and mouth and there was no injury noted.
Patient Sequence No: 1, Text Type: D, B5
[8563900]
At the time of this report, the device sample was not returned for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2010-00059 |
| MDR Report Key | 1732984 |
| Report Source | 00,06 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-05-10 |
| Date of Event | 2010-04-12 |
| Date Mfgr Received | 2010-05-10 |
| Date Added to Maude | 2011-01-28 |
| 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, MGR |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING RING BLADE RIGHT #2 |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 2010-06-04 |
| Model Number | 764PG |
| Catalog Number | 070330 |
| Lot Number | NOT PROVIDED |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-04 |