MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-04-15 for CONTIGEN-BARD COLLAGEN IMPLANT 651005 manufactured by C.r. Bard, Inc..
[20513905]
It was reported that five months after receiving the contigen implant, the patient went into urinary retention. Upon examination, the doctor observed a huge inflamed abscess in bladder neck and urethra that had to be drained. Called office in 2002 to determine patient's prognosis. Office staff had no information. Additional information has been requested via inquiry but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2002-00010 |
| MDR Report Key | 388704 |
| Report Source | 07 |
| Date Received | 2002-04-15 |
| Date of Report | 2002-04-15 |
| Date Mfgr Received | 2002-03-15 |
| Date Added to Maude | 2002-04-19 |
| 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 | CONTIGEN-BARD COLLAGEN IMPLANT |
| Generic Name | INCONTINENT IMPLANT |
| Product Code | LMI |
| Date Received | 2002-04-15 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 377753 |
| 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 | 2002-04-15 |