MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-06-04 for RED RUBBER CATHETER 8887-660085 manufactured by Kelsar, S.a..
[17827847]
Customer reports, that upon testing of the product for pyrogens using the lal test, the product yielded positive for endotoxins/pyrogens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1997-00009 |
| MDR Report Key | 96244 |
| Report Source | 06 |
| Date Received | 1997-06-04 |
| Date of Report | 1997-05-05 |
| Report Date | 1997-05-05 |
| Date Reported to Mfgr | 1997-05-05 |
| Date Mfgr Received | 1997-05-05 |
| Date Added to Maude | 1997-06-09 |
| 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 | RED RUBBER CATHETER |
| Generic Name | CATHETER |
| Product Code | FCN |
| Date Received | 1997-06-04 |
| Model Number | NA |
| Catalog Number | 8887-660085 |
| Lot Number | 803084 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 95021 |
| Manufacturer | KELSAR, S.A. |
| Manufacturer Address | 37 BLVD. INSURGENTES, LIBRIAMENTO A LA P., LA MESA TIJUANA, B.C. MX |
| Baseline Brand Name | RED RUBBER ROBINSON CATHETER, 8 FR |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-660085 |
| 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 | 1997-06-04 |