MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-08 for TIP, PERIO (SPARE PKG.) 261669 61669 manufactured by Dentalez Group.
[21379473]
Tip broke in half. Pt swallowed broken piece. Pt was sent to a gastro specialist, where broken piece was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520265-1998-00004 |
| MDR Report Key | 205320 |
| Report Source | 05 |
| Date Received | 1999-01-08 |
| Date of Report | 1999-01-08 |
| Date of Event | 1998-12-10 |
| Date Mfgr Received | 1998-12-10 |
| Date Added to Maude | 1999-01-12 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIP, PERIO (SPARE PKG.) |
| Generic Name | TITAN SCALER TIP PERIO |
| Product Code | ELB |
| Date Received | 1999-01-08 |
| Model Number | 261669 |
| Catalog Number | 61669 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 199307 |
| Manufacturer | DENTALEZ GROUP |
| Manufacturer Address | 1816 COLONIAL VILLAGE LN. LANCASTER PA 17601 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1999-01-08 |