MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-09-18 for BARD MALECOT DRAIN 086028 manufactured by C.r. Bard, Inc..
[89671]
When attempting to remove the suprapubic drain on 2nd post-op day following prostatectomy, the drain broke & the tip of drain remained in pt's bladder. Pt was taken to surgery & under spinal, drain tip was removed. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1997-00050 |
| MDR Report Key | 121324 |
| Report Source | 00 |
| Date Received | 1997-09-18 |
| Date of Event | 1997-08-14 |
| Date Facility Aware | 1997-08-14 |
| Date Mfgr Received | 1997-09-05 |
| Device Manufacturer Date | 1981-04-01 |
| Date Added to Maude | 1997-09-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | LATEX MALECOT DRAIN |
| Product Code | FEW |
| Date Received | 1997-09-18 |
| Model Number | NA |
| Catalog Number | 086028 |
| Lot Number | UNK |
| ID Number | UT1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 118860 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | BARD MALECOT DRAIN |
| Baseline Generic Name | MALECOT DRAIN |
| Baseline Model No | NA |
| Baseline Catalog No | 086028 |
| 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. Other | 1997-09-18 |