MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2011-02-08 for COLLAPLUG 0102 manufactured by Integra Lifesciences Corp..
[1955915]
The reporter stated that the seal on two packages of the sterile absorbable collagen wound dressing were broken when they were received at a dental office in (b)(6). Integra has requested return of the product complaint samples for evaluation. There was no adverse outcome for any patient.
Patient Sequence No: 1, Text Type: D, B5
[8832969]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2011-00004 |
| MDR Report Key | 2020388 |
| Report Source | 01,05,08 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-04 |
| Date Mfgr Received | 2011-01-25 |
| Date Added to Maude | 2012-02-06 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLAPLUG |
| Generic Name | DENTAL PRODUCTS |
| Product Code | LPG |
| Date Received | 2011-02-08 |
| Catalog Number | 0102 |
| Lot Number | 1102694 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-08 |