MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for TRU-CLOSE SUCTION DRAINAGE SYSTEM TCS300D manufactured by Uresil, Llc.
[179745063]
Elderly male with history of type 2 diabetes, prostate cancer, atrial fibrillation, chronic kidney disease, admitted with pelvic abbess. During a drainage procedure, a uresil drain bag was connected to the drain and no suction was being held, doctor inspected the bag and felt like there is a hole in the bag somewhere. A new drain bag was connected, and suction was held with no issue, procedure was completed without any further issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9719936 |
| MDR Report Key | 9719936 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-02-18 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | TRU-CLOSE SUCTION DRAINAGE SYSTEM |
| Generic Name | APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED |
| Product Code | GCY |
| Date Received | 2020-02-18 |
| Model Number | TCS300D |
| Catalog Number | TCS300D |
| Lot Number | 9F481 |
| 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 | 2020-02-18 |