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 |