MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-03 for LABORIE T-DOC-7FD manufactured by Laborie Medical Technologies Canada Ulc.
| Report Number | 8662250 |
| MDR Report Key | 8662250 |
| Date Received | 2019-06-03 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-03-11 |
| Report Date | 2019-05-29 |
| Date Reported to FDA | 2019-05-29 |
| Date Reported to Mfgr | 2019-06-03 |
| Date Added to Maude | 2019-06-03 |
| 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 | LABORIE T-DOC-7FD |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2019-06-03 |
| Model Number | T-DOC-7FD |
| Lot Number | 181680 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABORIE MEDICAL TECHNOLOGIES CANADA ULC |
| Manufacturer Address | UNISENSOR USA, INC. 112 CORPORATE DR STE 12 PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-03 |