MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-13 for ORAPLUG ORAPLUGPKG-10 manufactured by Integra Neurosciences Pr.
[2445604]
The reporter a dentist stated (pt #4) used the product to fill an extraction socket. A few days after the procedure, the pt developed signs of local infection such as pain and swelling. The pt also developed a late local abscess after extraction of tooth #30 when the product was used. She was treated with an incision and drainage. The healing is within normal.
Patient Sequence No: 1, Text Type: D, B5
[9561919]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2011-00041 |
| MDR Report Key | 2378450 |
| Report Source | 05 |
| Date Received | 2011-12-13 |
| Date of Report | 2011-12-13 |
| Date Mfgr Received | 2011-11-22 |
| Date Added to Maude | 2011-12-19 |
| 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 | MARIA D'AGOSTINO |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAPLUG |
| Generic Name | DENTAL PRODUCTS |
| Product Code | LPG |
| Date Received | 2011-12-13 |
| Catalog Number | ORAPLUGPKG-10 |
| Lot Number | 1112593 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-13 |