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.
[2445603]
The reporter a dentist stated (pt #2) used the product to fill an extraction socket. A few days after the procedure, signs of local infection such as pain and swelling developed. The pt had exudation from the socket after extraction of tooth #13 and the product was placed. The pt was treated with normal saline irrigation and an antibiotic. The pt did not come back for further eval. The dentist has not heard any complaint from the pt after that.
Patient Sequence No: 1, Text Type: D, B5
[9561918]
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 | 1121308-2011-00043 |
| MDR Report Key | 2378448 |
| 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 |