MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-02-27 for SILICONE FOLEY CATHETER 8887-603085 manufactured by Kelsar, S.a..
[92474]
Catheter balloon does not collapse completely. Leaves a ridge that cannot pass through the urethrea without severe pain and discomfort to the child.
Patient Sequence No: 1, Text Type: D, B5
[20079362]
One used and one unused sample were returned and evaluated. Visual inspection revealed no irregularities. Both samples were functionally evaluated and no problems were found. The french size of the balloons was within specification. No other complaints have been registered on this lot and the lot history search was unremarkable. Co testing has found that the speed with which the balloon is deflated is a factor in pruning (ridges formed on balloons). Slower deflation results is little or no ridges while rapid deflation increases pruning. We have advised the customer to insure that care is taken to deflate the balloon's slowly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-1998-00004 |
| MDR Report Key | 153596 |
| Report Source | 05,06 |
| Date Received | 1998-02-27 |
| Date of Report | 1998-01-28 |
| Report Date | 1998-01-28 |
| Date Mfgr Received | 1998-01-28 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 1998-03-04 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | SILICONE FOLEY CATHETER |
| Generic Name | CATHETER |
| Product Code | FCN |
| Date Received | 1998-02-27 |
| Returned To Mfg | 1998-02-24 |
| Model Number | NA |
| Catalog Number | 8887-603085 |
| Lot Number | 802540 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 149630 |
| Manufacturer | KELSAR, S.A. |
| Manufacturer Address | BLVD INSURGENTES PARCELA #37 LA MESA TIJUANA, B.C. MX |
| Baseline Brand Name | ALL SILICONE FOLEY CATHETER, 8 FR, 3CC |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-603085 |
| 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 | 1998-02-27 |