MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-09-18 for RED RUBBER ROBINSON CATHETER 8887-660168 manufactured by Kelsar, S.a..
[70389]
Customer reports he had injured himself twice by puncturing membrane and causing bleeding. He feels the id of the catheter is considerably smaller and the catheter is much stiffer.
Patient Sequence No: 1, Text Type: D, B5
[7762962]
Ninety samples were returned for evaluation. There was no visible defect of damage. Diameter of catheter was measured and was within specification. Lot history was reviewed and was unremarkable with regard to the complaint. No other complaints have been received against this lot. Natural variations in catheter material and/or dimensions may account for the customer's perceived difference.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-1997-00017 |
| MDR Report Key | 120711 |
| Report Source | 04 |
| Date Received | 1997-09-18 |
| Date of Report | 1997-08-19 |
| Date Reported to Mfgr | 1997-08-19 |
| Date Mfgr Received | 1997-08-19 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1997-09-19 |
| 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 ROBINSON CATHETER |
| Generic Name | DRAINAGE CATHETER |
| Product Code | FCN |
| Date Received | 1997-09-18 |
| Returned To Mfg | 1997-09-03 |
| Model Number | NA |
| Catalog Number | 8887-660168 |
| Lot Number | 805259 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 118340 |
| Manufacturer | KELSAR, S.A. |
| Manufacturer Address | 37 BLVD. INSURGENTES, LA MESA TIJUANA, B.C. MX |
| Baseline Brand Name | RED RUBBER ROBINSON CATHETER, 16 FR |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-660168 |
| 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 | 1997-09-18 |