MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-12-07 for COLLAPLUG 0102 manufactured by .
[1514950]
The distributor stated that a dentist who has been using collaplug in extraction sockets in almost every case for over two years has had some patients return the next day, and has observed that the collaplug is almost gone. The dentist reported that his technique was the same for all the cases, and that this has only been observed recently. Integra requested additional clinical info from the distributor. No additional info is available.
Patient Sequence No: 1, Text Type: D, B5
[8505010]
A review of integra's complaint system showed that this event was reported to integra, and entered into the complaint management system in (b)(4) 2009. A medwatch had not been submitted previously for this event. No unused collaplug medical devices have been returned for examination. No product identification code was provided, nor was a product lot number provided. Due to the unavailability of clinical info, no further action can be taken at this point. Root cause was not determined at this time as no product was returned for evaluation. A review of the complaint management system showed that no similar complaints have been recorded for this product in the past 3 years. Integra considers this complaint investigation closed. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2009-00032 |
| MDR Report Key | 1556527 |
| Report Source | 05,08 |
| Date Received | 2009-12-07 |
| Date of Report | 2009-12-07 |
| Date of Event | 2009-04-14 |
| Date Mfgr Received | 2009-04-14 |
| Date Added to Maude | 2010-07-16 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLAPLUG |
| Generic Name | DENTAL PRODUCTS |
| Product Code | LPG |
| Date Received | 2009-12-07 |
| Catalog Number | 0102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-07 |