MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-10-09 for ALL SILICONE FOLEY CATHETER 8887-605205 manufactured by Kelsar, S.a..
[81830]
Customer reports, after pretest a catheter was placed in the pt. The pt had undergone a prostectomy, post op radical surgery. The dr over inflated the balloon with 15 cc of water. During transfer to the gurney, the catheter was found out of the pt. They were able to replace the catheter without reopening the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1998-00019 |
| MDR Report Key | 191121 |
| Report Source | 06 |
| Date Received | 1998-10-09 |
| Date of Report | 1998-09-11 |
| Date of Event | 1998-09-10 |
| Date Facility Aware | 1998-09-10 |
| Report Date | 1998-09-11 |
| Date Reported to Mfgr | 1998-09-11 |
| Date Mfgr Received | 1998-09-11 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1998-10-14 |
| 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 | ALL SILICONE FOLEY CATHETER |
| Generic Name | CATHETER, UROLOGICAL |
| Product Code | FCN |
| Date Received | 1998-10-09 |
| Returned To Mfg | 1998-09-25 |
| Model Number | NA |
| Catalog Number | 8887-605205 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 185707 |
| Manufacturer | KELSAR, S.A. |
| Manufacturer Address | BLVD INSURGENTES PARCELA #37 LA MESA, TIJUANA MX |
| Baseline Brand Name | ALL SILICONE FOLEY CATHETER, 20 FR, 5CC |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-605205 |
| 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 | 1998-10-09 |