MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-10-04 for BARD CONTIGEN IMPLANT 651005 manufactured by C.r. Bard, Inc..
[258299]
It was reported that a pt received a contigen skin test in 2002 with a negative result. The contigen implant was performed in 2002. Within 24 hours of receiving the implant, the pt developed fever, chills and muscle aches. A few days later, pt became jaundiced. The pt was admitted to the hospital and underwent a cholecystectomy. The gall bladder pathology report was normal. A liver biopsy showed granulomatous hepatitis. The gastroenterologist said that it was unlikely that the hepatitis was related to contigen. After the hepatitis was resolved, the pt rec'd a 2nd contigen implant with spinal anesthesia 3 months later. Within 24 hours, the pt developed fever, aches, chills and abnormal liver function tests. Pt doing better, prognosis good, no permanent damage expected. Doctor states that he believes the hepatitis is related to the contigen implant. Add'l info has been requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2002-00028 |
| MDR Report Key | 420558 |
| Report Source | 05 |
| Date Received | 2002-10-04 |
| Date of Report | 2002-09-24 |
| Date Mfgr Received | 2002-08-22 |
| Date Added to Maude | 2002-10-08 |
| 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 | 2002-10-04 |
| 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 | 409612 |
| 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 | 2002-10-04 |