MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-05 for WHISPERPADSINFINITYINFINITYBASEVERWINGREGNORNONDO10CT manufactured by Hyginett Hungarian American Co.
Report Number | 1219109-2020-00001 |
MDR Report Key | 9671226 |
Report Source | CONSUMER,FOREIGN |
Date Received | 2020-02-05 |
Date of Report | 2019-12-22 |
Date of Event | 2019-12-01 |
Date Mfgr Received | 2020-01-06 |
Date Added to Maude | 2020-02-05 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
Manufacturer Street | WINTON HILL BUSINESS CENTER B6280 CENTER HILL AVENUE |
Manufacturer City | CINCINNATI OH 45224 |
Manufacturer Country | US |
Manufacturer Postal | 45224 |
Manufacturer G1 | HYGINETT HUNGARIAN AMERICAN CO |
Manufacturer Street | HATAR U.3 |
Manufacturer City | CSOMOR, |
Manufacturer Country | HU |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | WHISPERPADSINFINITYINFINITYBASEVERWINGREGNORNONDO10CT |
Generic Name | PAD, MENSTRUAL, UNSCENTED |
Product Code | HHD |
Date Received | 2020-02-05 |
Lot Number | NOT AVAILABLE |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HYGINETT HUNGARIAN AMERICAN CO |
Manufacturer Address | HATAR U.3 CSOMOR, HU |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-05 |