MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1998-09-25 for FOLEY CATHETER 8887-605122 manufactured by Kelsar, Sa ..
[100076]
Customer reports, catheter was inserted in pt in labor ward. The pt was then transferred to the theater for a c-section. The catheter dislodged falling out. The balloon was deflated and the tip of the catheter was missing, halfway along slit (above balloon) to tip. The catheter appeared to have a clear cut through the slit above the catheter. Pt bladder was palpated without success. Therefore, the staff feel the catheter was faulty before being inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1998-00018 |
| MDR Report Key | 189061 |
| Report Source | 01,06 |
| Date Received | 1998-09-25 |
| Report Date | 1998-08-27 |
| Date Reported to Mfgr | 1998-08-27 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 1998-09-28 |
| 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, URINARY |
| Product Code | FCN |
| Date Received | 1998-09-25 |
| Model Number | NA |
| Catalog Number | 8887-605122 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 183724 |
| Manufacturer | KELSAR, SA . |
| Manufacturer Address | BLVD. INSURGENTES, PARCELA #37 LA MESA TIJUANA BC * |
| Baseline Brand Name | ALL SILICONE FOLEY CATHETER, 12 FR, 5CC |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-605122 |
| 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 | 1998-09-25 |