MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for GP GENERAL PURPOSE DRAINAGE CATHETER GPL2-1030H manufactured by Uresil, Llc.
[177959919]
Elderly female with abscess in abdominal cavity. Ct retroperitoneal abscess and uresil catheter inserted, flushed and checked by physician before completing procedure. After patient returned to floor, catheter leaked when flushed. Physician that inserted it went to floor to check it and it indeed, leaked. Another procedure was done to remove and replace the catheter. Pinhole present in catheter that was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9675888 |
| MDR Report Key | 9675888 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-28 |
| Report Date | 2020-01-30 |
| Date Reported to FDA | 2020-01-30 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | GP GENERAL PURPOSE DRAINAGE CATHETER |
| Generic Name | CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY |
| Product Code | GBO |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-01-31 |
| Model Number | GPL2-1030H |
| Catalog Number | GPL2-1030H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | URESIL, LLC |
| Manufacturer Address | 5418 WEST TOUHY AVE SKOKIE IL 60077 US 60077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |