MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for GP GENERAL PURPOSE DRAINAGE CATHETER GPL2-0830H manufactured by Uresil, Llc.
[176429577]
Female with large abscess between the uterus and the rectum. Interventional radiologist drained the abscess using computed tomography guided placement, "uresil drain catheter crack at the hub while hooking it to the drain bag, doctor had to exchange the catheter for a different one of a different brand. The crack caused an air leak which then we would lose the suction we would need to draw out the infection. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9632290 |
| MDR Report Key | 9632290 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-13 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-01-27 |
| Date Added to Maude | 2020-01-27 |
| 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 | 2020-01-27 |
| Model Number | GPL2-0830H |
| Catalog Number | GPL2-0830H |
| Lot Number | 9F489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-01-27 |