MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1998-07-15 for FOLEY CATHETER 8887-605148 manufactured by Kelsar Sa..
[100283]
Customer reports when balloon is deflated, ridging occurs from deflated balloon. Withdrawn suprapubic, extra resistance is felt because of ridging and can cause trauma when withdrawn, ie, bleeding. Damage to suture line particularly in radical procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1998-00016 |
| MDR Report Key | 177311 |
| Report Source | 01,06 |
| Date Received | 1998-07-15 |
| Date of Report | 1998-06-15 |
| Report Date | 1998-06-15 |
| Date Reported to Mfgr | 1998-06-15 |
| Date Mfgr Received | 1998-06-15 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1998-07-17 |
| 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 | FOLEY CATHETER |
| Generic Name | CATHETER, FOLEY |
| Product Code | FCN |
| Date Received | 1998-07-15 |
| Model Number | NA |
| Catalog Number | 8887-605148 |
| Lot Number | 806491 |
| ID Number | NA |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 172415 |
| Manufacturer | KELSAR SA. |
| Manufacturer Address | BLVD INSURGENTES, PARCELA #37 LA MESA, TIJUANA BC * |
| Baseline Brand Name | ALL SILICONE FOLEY CATHETER, 14 FR, 5CC |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-605148 |
| 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 | 1998-07-15 |