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.
[74762]
Device first placed on 4/14/97. Cath was checked for leakage and output was recorded, no other documentation of care in pt's record. Pt was released w/device which was removed on 4/18/97. Pt re-admitted on 4/20/97 w/significant penile irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-1997-00058 |
| MDR Report Key | 135603 |
| Report Source | 05 |
| Date Received | 1997-12-01 |
| Date of Event | 1997-04-26 |
| 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 | 125220 |
| 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 |