MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-16 for LENA CUP manufactured by Lena Cup Llc.
| Report Number | 3011660924-2019-00015 |
| MDR Report Key | 9197961 |
| Date Received | 2019-10-16 |
| Date Mfgr Received | 2019-10-12 |
| Date Added to Maude | 2019-10-16 |
| 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 | MR. REY OBNAMIA |
| Manufacturer Street | 1035 CALLE AMANECER |
| Manufacturer City | SAN CLEMENTE CA 92673 |
| Manufacturer Country | US |
| Manufacturer Postal | 92673 |
| Manufacturer G1 | IRP MEDICAL |
| Manufacturer Street | 1035 CALLE AMANECER |
| Manufacturer City | SAN CLEMENTE CA 92673 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92673 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LENA CUP |
| Generic Name | MENSTRUAL CUP |
| Product Code | HHE |
| Date Received | 2019-10-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LENA CUP LLC |
| Manufacturer Address | 244 FIFTH AVENUE #2243 NEW YORK NY 10001 US 10001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-10-16 |