MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-01-16 for BARD CONTIGEN IMPLANT 651005 manufactured by C.r. Bard, Inc..
[308550]
It was reported that two weeks following a contigen implant procedure performed in 2002, the patient returned to doctor complaining of pain during urination. The urinalysis was normal indicating no infection. The doctor scoped the patient and found a small, hard, yellowish nodule on the left side of the urethra. The doctor excised the nodule 2 months later and sent the patient home. In 2003, the patient came back complaining of pain and was seen by a different doctor. Upon examination, the doctor found a raw, open area where the nodule had been removed. The doctor cauterized the area and sent the patient home. There have been no further complications. The patient is still continent and has healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2002-00046 |
| MDR Report Key | 438272 |
| Report Source | 00 |
| Date Received | 2003-01-16 |
| Date of Report | 2003-01-16 |
| Date of Event | 2002-12-09 |
| Date Facility Aware | 2002-12-09 |
| Date Mfgr Received | 2002-12-19 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2003-01-22 |
| 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, MANAGER |
| 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 | 2003-01-16 |
| Model Number | NA |
| Catalog Number | 651005 |
| Lot Number | 03HM2014 |
| ID Number | NA |
| Device Expiration Date | 2005-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 427190 |
| 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 | 2003-01-16 |