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 |