MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1997-05-07 for ALL SILICONE FOLEY CATHETER 8887-603085 manufactured by Kelsar, S.a..
[56581]
Customer reports that the catheter balloon became baggy after deflating. The pt's urethra was reportedly "damaged".
Patient Sequence No: 1, Text Type: D, B5
[7827853]
The balloon was completely functional; the slight ridge noted over the balloon area was measured and found to be within specification. The ridge on the balloon is a natural condition due to the inherent physical properties of the balloon material. No corrective action is necessary. Please note that this report may be based.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-1997-00008 |
| MDR Report Key | 89063 |
| Report Source | 01,06 |
| Date Received | 1997-05-07 |
| Date of Report | 1997-04-10 |
| Report Date | 1997-04-10 |
| Date Reported to Mfgr | 1997-04-10 |
| Date Mfgr Received | 1997-04-10 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 1997-05-08 |
| 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 | FOLEY CATHETER |
| Product Code | FCN |
| Date Received | 1997-05-07 |
| Returned To Mfg | 1997-04-14 |
| Model Number | NA |
| Catalog Number | 8887-603085 |
| Lot Number | 899875 |
| ID Number | VALVE #026616 |
| Operator | OTHER |
| 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 | 88059 |
| Manufacturer | KELSAR, S.A. |
| Manufacturer Address | 37 BLVD. INSURGENTES, LIBRIAMENTO A LA P., 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 | 1. Other | 1997-05-07 |