MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-12-30 for BARD MALECOT DRAIN 086010 manufactured by C.r. Bard, Inc..
[165566]
Drain placed suprapubically following a bilateral ureteral reimplantation. During removal attempts ten days later, the drain head separated from the shaft and remained inside the pt's bladder. Pt was anesthetized and broken drain portion was removed transurethrally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1998-00021 |
| MDR Report Key | 204374 |
| Report Source | 07 |
| Date Received | 1998-12-30 |
| Date of Report | 1998-12-30 |
| Date of Event | 1998-11-30 |
| Date Mfgr Received | 1998-12-02 |
| Date Added to Maude | 1999-01-05 |
| 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 |
| 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 | 1998-12-30 |
| Returned To Mfg | 1998-12-11 |
| Model Number | NA |
| Catalog Number | 086010 |
| Lot Number | UNK |
| ID Number | H2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 198503 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | BARDEX MALECOT LATEX DRAIN |
| Baseline Generic Name | MALECOT DRAIN |
| Baseline Model No | NA |
| Baseline Catalog No | 086010 |
| Baseline ID | NA |
| Baseline Device Family | LATEX MALECOT DRAIN |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910197 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-30 |