MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-01-18 for GARDENT TEETH GUARDS * 502275 manufactured by Pilling Surgical.
[401832]
Tooth protector split
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515651-2005-00001 |
| MDR Report Key | 584820 |
| Report Source | 06 |
| Date Received | 2005-01-18 |
| Date of Report | 2004-12-14 |
| Date of Event | 2004-10-18 |
| Date Mfgr Received | 2004-12-14 |
| Date Added to Maude | 2005-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRADLEY SEIDEN MGR |
| Manufacturer Street | 200 PRECISION ROAD SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2154428892 |
| Manufacturer G1 | PILLING SURGICAL |
| Manufacturer Street | 200 PRECISION ROAD SUITE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GARDENT TEETH GUARDS |
| Generic Name | GUARD |
| Product Code | BRW |
| Date Received | 2005-01-18 |
| Model Number | * |
| Catalog Number | 502275 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 574647 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | 200 PRECISION RD. SUITE 200 HORSHAM PA 19044 US |
| Baseline Brand Name | GARDENT TEETH GUARDS |
| Baseline Generic Name | GUARD |
| Baseline Model No | * |
| Baseline Catalog No | 502275 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-18 |