MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-04-16 for BARD CONTIGEN IMPLANT 651005 manufactured by C.r. Bard, Inc..
[221279]
Patient developed urethra hypersensitivity and painful urination 2 weeks after contigen implant. Skin test remains clear with no signs of a reaction. Doctor had not performed any urine culture or any testing to diagnose patient. On 4/9/01, follow-up with reporter indicated patient was still experiencing burning and itching sensation after having been treated with topical steroids. Several cultures were reportedly performed with no growth detected. Doctor was bringing patient in for a washout procedure intended to remove the contigen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2001-00011 |
| MDR Report Key | 327653 |
| Report Source | 00 |
| Date Received | 2001-04-16 |
| Report Date | 2001-04-12 |
| Date Mfgr Received | 2001-04-10 |
| Date Added to Maude | 2001-04-20 |
| 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 | 7707846902 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD CONTIGEN IMPLANT |
| Generic Name | INCONTINENCE IMPLANT |
| Product Code | LMI |
| Date Received | 2001-04-16 |
| Model Number | NA |
| Catalog Number | 651005 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 317034 |
| 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 | 2001-04-16 |