MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-11 for 25217 manufactured by Tidi Products Llc.
| Report Number | 2182318-2019-00007 |
| MDR Report Key | 9305810 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-11 |
| Date of Report | 2019-11-11 |
| Date of Event | 2017-11-08 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2019-11-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS RAHN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25217 |
| Generic Name | URO-DRAIN COLLECTION BAG |
| Product Code | MMZ |
| Date Received | 2019-11-11 |
| Model Number | 25217 |
| Lot Number | 1153530816 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS LLC |
| Manufacturer Address | 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-11 |