MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for L.TAMPONSORGCOTTON manufactured by Ontex Hygieneartikel Gmbh.
| Report Number | 9615100-2020-00006 |
| MDR Report Key | 9878062 |
| Report Source | CONSUMER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | ONTEX HYGIENEARTIKEL GMBH |
| Manufacturer City | GROSSPOSTWITZ, SACHSEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L.TAMPONSORGCOTTON |
| Generic Name | TAMPON, MENSTRUAL, UNSCENTED |
| Product Code | HEB |
| Date Received | 2020-03-25 |
| 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 | ONTEX HYGIENEARTIKEL GMBH |
| Manufacturer Address | GROSSPOSTWITZ, SACHSEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |