MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for UNKNOWN TRUCLEAR DEVICE manufactured by Covidien Mansfield.
[185012025]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185012026]
According to the reporter, during a myomectomy while resecting the tissue, the unit was reading a negative deficit when the case was at negative 800. At the end of the procedure, the manual count was a lot higher than 2500. It was noted that there was fluid on the floor which would contribute to the loss. The electrolyte was asked to be taken to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2020-00010 |
| MDR Report Key | 9882444 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MANSFIELD |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TRUCLEAR DEVICE |
| Generic Name | HYSTEROSCOPE (AND ACCESSORIES) |
| Product Code | HIH |
| Date Received | 2020-03-26 |
| Model Number | UNKNOWN TRUCLEAR DEVICE |
| Catalog Number | UNKNOWN TRUCLEAR DEVICE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MANSFIELD |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |