MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-23 for PLAYTEX TAMPON UNKNOWN manufactured by Playtex Manufacturing Inc..
| Report Number | 2515444-2020-00001 |
| MDR Report Key | 9866452 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-23 |
| 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 | MS. JANET GONZALEZ |
| Manufacturer Street | 75 COMMERCE DRIVE |
| Manufacturer City | ALLENDALE, NJ |
| Manufacturer Country | US |
| Manufacturer Phone | 7858047 |
| Manufacturer G1 | EDGEWELL PERSONAL CARE BRANDS |
| Manufacturer Street | 804 WALKER RD |
| Manufacturer City | DOVER, DE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX TAMPON UNKNOWN |
| Generic Name | MENSTRUAL TAMPON |
| Product Code | HEB |
| Date Received | 2020-03-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING INC. |
| Manufacturer Address | 804 WALKER RD. DOVER, DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-23 |