MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-08 for HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM STAND 7210165 manufactured by Covidien Mansfield.
[174141644]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[174141645]
According to the reporter, prior to use, the device's scale was not registering correct volume. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2020-00002 |
| MDR Report Key | 9562198 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-08 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM STAND |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC |
| Product Code | HIG |
| Date Received | 2020-01-08 |
| Model Number | 7210165 |
| Catalog Number | 7210165 |
| 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 | 2020-01-08 |