MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-11-15 for CONTIGEN BARD COLLAGEN IMPLANT 651005 manufactured by C.r. Bard, Inc..
[200901]
Approximately 2 to 3 years ago, dr treated pt with 6 to 7 injections of contigen. In march of 2000, pt developed a delayed skin test reaction with possible cellulitis/abcess formation on forearm. Urologist consult found open wounds in the bladder at the area of the injection sites and found that the trigone of the bladder was bulked up. The open wounds have healed with treatment. Currently, pt has redness at skin test site and inside trigone of bladder at injection site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2000-00031 |
| MDR Report Key | 305201 |
| Report Source | 00 |
| Date Received | 2000-11-15 |
| Date of Report | 2000-11-15 |
| Date of Event | 2000-03-01 |
| Date Mfgr Received | 2000-10-25 |
| Date Added to Maude | 2000-11-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIVIAN STEPHENS, MGR |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846602 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTIGEN BARD COLLAGEN IMPLANT |
| Generic Name | INCONTINENT IMPLANT |
| Product Code | LMI |
| Date Received | 2000-11-15 |
| Model Number | NA |
| Catalog Number | 651005 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 295371 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | CONTIGEN BARD COLLAGEN IMPLANT |
| Baseline Generic Name | INCONTINENCE IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 651005 |
| Baseline ID | NA |
| Baseline Device Family | BARD CONTIGEN IMPLANT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-11-15 |