MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-02-03 for BARD CONTIGEN TRANSURETHRAL INJECTION SYSTEM 652200 manufactured by C.r. Bard, Inc..
[348119]
Following a transurethral injection of a continence implant procedure, the doctor removed the cystoscope and the transurethral sheath and found the needle was missing from the sheath. The doctor could not find the needle so an a-p film was performed and the needle was projected over a region of the penis and scrotum. The doctor was unable to pinpoint the exact location of the needle which would have necessitated an open procedure to locate. The doctor plans to bring the patient back in 3 to 4 weeks and perform a cystoscopy and try to remove the needle at this point. There were a total of five injections made with the needle and no reported occurrences of any difficulty in passing the needle during the injection periods.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2005-00001 |
| MDR Report Key | 570675 |
| Report Source | 06 |
| Date Received | 2005-02-03 |
| Date of Report | 2005-02-03 |
| Date of Event | 2004-12-28 |
| Date Mfgr Received | 2005-01-05 |
| Date Added to Maude | 2005-02-08 |
| 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 | 3 |
| 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 TRANSURETHRAL INJECTION SYSTEM |
| Generic Name | TRANSURETHRAL NEEDLE |
| Product Code | LMI |
| Date Received | 2005-02-03 |
| Model Number | NA |
| Catalog Number | 652200 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 560523 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | BARD CONTIGEN TRANSURETHRAL INJECTION SYSTEM |
| Baseline Generic Name | TRANSURETHRAL NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 652200 |
| Baseline ID | NA |
| Baseline Device Family | CONTIGEN TRANSURETHRAL INJECTION SYSTEM |
| Baseline Shelf Life Contained | A |
| 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 | 2005-02-03 |