MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-03-03 for COLLATAPE 0100 manufactured by Integra Lifesciences.
[193561]
Integra lifesciences corp was contacted regarding this incident by the spouse of the patient in question on february 4, 2000. Surgery was performed in 1999 for removal of a nasal palantine cyst. Approximately 1 week after the procedure the oral surgeon noted a white material extruded from the surgical site. This white material was not identified. The patient experienced pain, and in 1999 underwent an additional surgery at the same site, performed by a different oral surgeon. This surgeon indicated that fibrous material was removed from the site. The patient experienced no relief from pain. In 1999 a third surgery was performed by the second surgeon, who indicated amorphous material was removed and the bone appeared normal. Biopsy concluded dense scar tissue was present. Patient still experienced no relief from the pain. Marcaine was injected into the surgical site approximately one week before this report was received by integra lifesciences corp. This resulted in some pain relief.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2000-00001 |
| MDR Report Key | 266946 |
| Report Source | 00 |
| Date Received | 2000-03-03 |
| Date of Report | 2000-02-04 |
| Date of Event | 1999-02-19 |
| Date Mfgr Received | 2000-02-04 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2000-03-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ALLISON STEELE |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6092750500 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLATAPE |
| Generic Name | COLLAGEN WOUND DRESSING |
| Product Code | LPG |
| Date Received | 2000-03-03 |
| Model Number | NA |
| Catalog Number | 0100 |
| Lot Number | 8003400 |
| ID Number | NA |
| Device Expiration Date | 2001-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 258420 |
| Manufacturer | INTEGRA LIFESCIENCES |
| Manufacturer Address | 105 MORGAN LANE PLAINSBORO NJ 08536 US |
| Baseline Brand Name | COLLATAPE |
| Baseline Generic Name | COLLAGEN WOUND DRESSING |
| Baseline Model No | NA |
| Baseline Catalog No | 0100 |
| Baseline ID | NA |
| Baseline Device Family | ABSORBABLE COLLAGEN WOUND DRESSINGS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8400 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-03 |