MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-04 for SILICONE FOLEY CATHETER 8887-675166 manufactured by Kelsar Sa.
[105208]
Customer reports, twice during the past two weeks the doctor has inflated the foley catheter and then was unable to deflate it. Both happened during radical prostatectomies. No pt injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1998-00017 |
| MDR Report Key | 185550 |
| Report Source | 05,06 |
| Date Received | 1998-09-04 |
| Date of Report | 1998-08-10 |
| Date of Event | 1998-08-03 |
| Date Facility Aware | 1998-08-03 |
| Report Date | 1998-08-10 |
| Date Reported to Mfgr | 1998-08-10 |
| Date Mfgr Received | 1998-08-10 |
| Date Added to Maude | 1998-09-08 |
| 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 | SILICONE FOLEY CATHETER |
| Generic Name | CATHETER, FOLEY |
| Product Code | FCN |
| Date Received | 1998-09-04 |
| Model Number | NA |
| Catalog Number | 8887-675166 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 180358 |
| Manufacturer | KELSAR SA |
| Manufacturer Address | BLVD. INSURGENTES, PARCELA #37 LA MESA TIJUANA BC * |
| Baseline Brand Name | SILICONE ELASTOMER COATED LATEX FOLEY CATHETER |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-675166 |
| Baseline ID | * |
| Baseline Device Family | UROLOGICAL CATHETER & ACCESSORIES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810630 |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-09-04 |