MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-03-17 for MALECOT DRAIN UNK manufactured by C.r. Bard, Inc..
[21962475]
It was alleged that a fragment of latex from drain was left on pt's bladder upon removal of the drain. Drain was initially placed in infant 4/88 due to urination difficulties. Approx 7 years later when dr was investigating urination problems with same pt, a fragment was found in bladder which resembled a "calcified rubber cross. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1997-00016 |
| MDR Report Key | 77219 |
| Report Source | 00 |
| Date Received | 1997-03-17 |
| Date of Report | 1997-03-14 |
| Date of Event | 1995-09-27 |
| Report Date | 1997-03-14 |
| Date Mfgr Received | 1997-02-14 |
| Date Added to Maude | 1997-03-21 |
| 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 | ATTORNEY |
| 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 | MALECOT DRAIN |
| Generic Name | MALECOT DRAIN |
| Product Code | FEW |
| Date Received | 1997-03-17 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 76938 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-17 |