MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-05-28 for URINE DRAIN BAG 8887-601600 manufactured by Kelsar Sa.
[7828900]
Three samples were returned and evaluated. Functional testing on the anti-reflux connector for ventt filter function found one unit defective. This item is purchased from a vendor. Record review found co's incoming inspection found no defects for connector failures. The mfg plant will notify the vendor so that they can determine the root cause of the defect and detail corrective action. Please note that this report may be based upon info not yet verified by sherwood davis and geck to be complete and accurate. Furthermore, this report does not necessarily reflect a conclusion or admission by sherwood davis and geck that one of it products has caused or contributed to a death or a serious injury or that one of its products has malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
[16613978]
Customer reports, drain bag did not allow the urine to flow into the tubing due to a "restriction" at the top of the connector or tubing. As a result urine could not flow into the bag and the pt contracted a kideny infection which required him to spend two additional weeks in the hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-1998-00011 |
| MDR Report Key | 169126 |
| Report Source | 05,06 |
| Date Received | 1998-05-28 |
| Date of Report | 1998-04-29 |
| Date of Event | 1998-03-31 |
| Date Facility Aware | 1998-03-31 |
| Report Date | 1998-04-29 |
| Date Reported to Mfgr | 1998-04-29 |
| Date Mfgr Received | 1998-04-29 |
| Date Added to Maude | 1998-05-29 |
| 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 | URINE DRAIN BAG |
| Generic Name | DRAIN BAG |
| Product Code | FCN |
| Date Received | 1998-05-28 |
| Returned To Mfg | 1998-05-07 |
| Model Number | NA |
| Catalog Number | 8887-601600 |
| Lot Number | 807896 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 164504 |
| Manufacturer | KELSAR SA |
| Manufacturer Address | BLVD. INSURGENTES, PARCELA #37 LA MESA, TIJUANA BC * |
| Baseline Brand Name | ANTI-REFLUX DRAINAGE BAG, URINE W/FLO-CHEK |
| Baseline Generic Name | URINARY DRAIN BAG |
| Baseline Model No | * |
| Baseline Catalog No | 8887-601600 |
| 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. Hospitalization | 1998-05-28 |