MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-12-01 for 1502M manufactured by Cr Bard Inc.
[74760]
Pt developed hydronephrosis after condom catheter was placed 2/20/97. Catheter was removed 2/24/97 after ultrasound revealed bilateral hydronephrosis cath had been checked for leakage and output had been recorded. There was no other documentation of care in pt's record. Pt transferred to tertiary ctr 2/25/97 where partial penectomy performed w/17 to days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1997-00059 |
| MDR Report Key | 135593 |
| Report Source | 05 |
| Date Received | 1997-12-01 |
| Date of Event | 1997-02-24 |
| Date Mfgr Received | 1997-11-04 |
| Date Added to Maude | 1997-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 1997-12-01 |
| Model Number | NA |
| Catalog Number | 1502M |
| Lot Number | UNK |
| ID Number | UNK |
| 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 | 125224 |
| Manufacturer | CR BARD INC |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US |
| Baseline Brand Name | BARDIC URO-SHEATH |
| Baseline Generic Name | MALE EXTERNAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 1502M |
| Baseline ID | NA |
| Baseline Device Family | BARDIC URO-SHEATH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K802433 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-01 |