MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-26 for 3T 1003062 manufactured by Premier Dental Products Co..
[50396271]
Patient Sequence No: 1, Text Type: N, H10
[50396272]
During a dental procedure an instrument broke in the patient's mouth during use. The patient had a throat pack in during procedure. Surgeon was able to retrieve the missing piece and both pieces of the instrument were removed from the field and saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5821721 |
| MDR Report Key | 5821721 |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-20 |
| Date of Event | 2016-07-01 |
| Report Date | 2016-07-20 |
| Date Reported to FDA | 2016-07-20 |
| Date Reported to Mfgr | 2016-07-20 |
| Date Added to Maude | 2016-07-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3T |
| Generic Name | FORCEPS, RONGEUR, SURGICAL |
| Product Code | EMH |
| Date Received | 2016-07-26 |
| Model Number | 3T |
| Catalog Number | 1003062 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PREMIER DENTAL PRODUCTS CO. |
| Manufacturer Address | 1710 ROMANO DRIVE PLYMOUTH MEETING PA 19462 US 19462 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-26 |