MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for INTIMINA LILY CUP COMPACT A manufactured by Lelo Inc.
[183515850]
Purchased intimina lily cup menstrual period collection device. (i bought the correct fit and have used intravaginal birth control devices prior so i am familiar with use of intravaginal devices). This cup created so much suction / vacuum on the cervix that i was unable to remove on my own. I have tried valsalva maneuvers and squatting to try to get it out but ended up having a physician remove it using a speculum and ring forceps, very painful. No longer have the product the dr threw it in the biohazard. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093673 |
| MDR Report Key | 9818436 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-02-25 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTIMINA LILY CUP COMPACT A |
| Generic Name | CUP, MENSTRUAL |
| Product Code | HHE |
| Date Received | 2020-03-10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LELO INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-10 |