MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-31 for T-DOC URODYNAMIC CATHETER TDOC-7FD manufactured by Isomedix Operations Inc..
[71382364]
Patient Sequence No: 1, Text Type: N, H10
[71382365]
At the "y" where the two catheters meet, it was leaking from there... We were unable to use, there must have been a small hole in the tubing at that point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6449177 |
| MDR Report Key | 6449177 |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-03-10 |
| Report Date | 2017-03-24 |
| Date Reported to FDA | 2017-03-24 |
| Date Reported to Mfgr | 2017-03-24 |
| Date Added to Maude | 2017-03-31 |
| 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 |
| 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 | T-DOC URODYNAMIC CATHETER |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2017-03-31 |
| Catalog Number | TDOC-7FD |
| Lot Number | 161496 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOMEDIX OPERATIONS INC. |
| Manufacturer Address | 9120 SOUTH 150 EAST SANDY UT 84070 US 84070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-31 |