MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-29 for DOVER SILICONE FOLEY CATHETER TRAY 8887-641762 manufactured by Kelsar, S.a..
[97573]
Customer reports, the pt was unable to void after surgery. They were unable to insert foley catheter. A bedside cystoscopy was done with 600+ cc's of bloody urine returned.
Patient Sequence No: 1, Text Type: D, B5
[7764405]
Reference mfr complaint #tj1998-3-31-252. No samples were returned for eval. No lot id info was provided; therefore, no lot history check was possible. We will reopen for complaint if samples become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-1998-00008 |
| MDR Report Key | 164918 |
| Report Source | 05,06 |
| Date Received | 1998-04-29 |
| Date of Report | 1998-02-02 |
| Date of Event | 1998-01-15 |
| Date Facility Aware | 1998-01-15 |
| Report Date | 1998-02-02 |
| Date Reported to FDA | 1998-03-12 |
| Date Reported to Mfgr | 1998-03-31 |
| Date Mfgr Received | 1998-03-31 |
| Date Added to Maude | 1998-04-30 |
| 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 | DOVER SILICONE FOLEY CATHETER TRAY |
| Generic Name | FOLEY CATHETER |
| Product Code | FCN |
| Date Received | 1998-04-29 |
| Model Number | NA |
| Catalog Number | 8887-641762 |
| 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 | 152218 |
| Manufacturer | KELSAR, S.A. |
| Manufacturer Address | BLVD. INSURGENTES, PARCELA #37 LA MESA, TIJUANA, B.C. * |
| Baseline Brand Name | CLOSED SYSTEM FOLEY CATHETER TRAY, SILICONE |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-641762 |
| 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 | 1. Required No Informationntervention | 1998-04-29 |