MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-06-12 for COLLAPLUG 1CM X 2CM 0102 manufactured by Integra Lifesciences.
[15703814]
Dentist reported that the implanted collagen material used apparently caused a delayed hypersensativity reaction in a pt several weeks after the implantantion. Implantation date was 2000. Dentist did not know the date of the onset of symptoms. Pt reported rash and itching, but did not report symptoms to the dentist until after symptoms had resolved. Pt reported an allergy to beef after incident occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2000-00006 |
| MDR Report Key | 281423 |
| Report Source | 08 |
| Date Received | 2000-06-12 |
| Date of Report | 2000-05-12 |
| Date Mfgr Received | 2000-05-12 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2000-06-14 |
| 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 | COLLAPLUG 1CM X 2CM |
| Generic Name | ABSORBABLE COLLAGEN WOUND DRESSING |
| Product Code | LPG |
| Date Received | 2000-06-12 |
| Model Number | NA |
| Catalog Number | 0102 |
| Lot Number | UNK |
| ID Number | NA |
| Device Expiration Date | 2003-03-01 |
| 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 | 272357 |
| Manufacturer | INTEGRA LIFESCIENCES |
| Manufacturer Address | 105 MORGAN LN. PLAINSBORO NJ 08536 US |
| Baseline Brand Name | COLLAPLUG |
| Baseline Generic Name | COLLAGEN WOUND DRESSING |
| Baseline Model No | NA |
| Baseline Catalog No | 0102 |
| 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 | 2000-06-12 |