MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-28 for DONUT PESS 2-1/4 IN #1 MXPDO01 manufactured by Coopersurgical, Inc..
Report Number | 1216677-2020-00015 |
MDR Report Key | 9639470 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-01-28 |
Date of Report | 2020-01-25 |
Date of Event | 2019-12-13 |
Date Mfgr Received | 2020-01-13 |
Date Added to Maude | 2020-01-28 |
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 | MR. PETER NIZIOLEK |
Manufacturer Street | 50 CORPORATE DRIVE |
Manufacturer City | TRUMBULL CT 06611 |
Manufacturer Country | US |
Manufacturer Postal | 06611 |
Manufacturer Phone | 2036015200 |
Manufacturer G1 | COOPERSURGICAL, INC. |
Manufacturer Street | 75 CORPORATE DRIVE |
Manufacturer City | TRUMBULL CT 06611 |
Manufacturer Country | US |
Manufacturer Postal Code | 06611 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | DONUT PESS 2-1/4 IN #1 |
Generic Name | DONUT PESS 2-1/4 IN #1 |
Product Code | HHW |
Date Received | 2020-01-28 |
Model Number | MXPDO01 |
Catalog Number | MXPDO01 |
Lot Number | NOT PROVIDED |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COOPERSURGICAL, INC. |
Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-01-28 |