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 2009-11-06 for COLLAPLUG manufactured by Integra Lifesciences Corp..
[18488399]
The reporter stated that the product - collaplug bovine collagen dental dressing, caused inflammation, swelling and soreness when used in a dental procedure. Unspecified intervention was required. Integra has requested additional info from the reporter.
Patient Sequence No: 1, Text Type: D, B5
[18595004]
A review of the complaint system indicated that this event has not been reported previously. A review of the device history record showed no anomalies for this lot. Integra has requested additional clinical and pt info from the reporter. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2009-00027 |
| MDR Report Key | 1525448 |
| Report Source | 01,05,08 |
| Date Received | 2009-11-06 |
| Date of Report | 2009-11-19 |
| Date of Event | 2008-11-17 |
| Date Facility Aware | 2008-12-02 |
| Date Mfgr Received | 2008-12-02 |
| Date Added to Maude | 2010-08-21 |
| 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 | NONE |
| Product Code | LPG |
| Date Received | 2009-11-06 |
| Returned To Mfg | 2009-04-14 |
| Lot Number | 1070223 |
| Device Expiration Date | 2010-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2009-11-06 |