MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-01-15 for BARD MALECOT DRAIN UNK manufactured by C.r. Bard, Inc..
[341983]
As reported by patient, suprapubic tube reportedly split causing leakage and subsequent surgical replacement. Patient had surgery for urethral stricture and placement of suprapubic tube in 11/2003. Three weeks later, patient experienced pain, blockage and leakage at stoma. Patient went to the e. R. And had surgery the next day, to remove and replace suprapubic tube with an all-silicone foley catheter. According to the doctor's report, the patient tolerated the procedure well and there were no complications. The tube was discarded by the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2004-00001 |
| MDR Report Key | 507102 |
| Report Source | 00 |
| Date Received | 2004-01-15 |
| Date of Report | 2004-01-15 |
| Date of Event | 2003-12-08 |
| Date Facility Aware | 2003-12-08 |
| Date Mfgr Received | 2004-01-05 |
| Date Added to Maude | 2004-01-22 |
| 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 | 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 | BARD MEDICAL |
| Manufacturer Street | 428 POWERHOUSE RD. |
| Manufacturer City | MONCKS CORNER SC 29461 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29461 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD MALECOT DRAIN |
| Generic Name | MALECOT DRAIN |
| Product Code | FEW |
| Date Received | 2004-01-15 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 496026 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-15 |