MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-18 for SAALT SMALL MENSTRUAL CUP manufactured by Saalt, Llc.
[183551211]
Customer reached out via (b)(6) on (b)(6) 2019 letting us know she tried removal multiple times and asked husband for assistance as she could not remove it on her own. Customer went to a medical clinic after calling nurse advice line, and looking for information on removal on the internet. Doctor removed cup at the clinic. Saalt sent follow up on 10/24/2019, 11/6/2019 and 11/15/2019 without any customer response to learn more about her visit to the doctor and to offer refund for the cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20041 |
| MDR Report Key | 9720754 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2020-02-18 |
| 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 | DANIELLE BURDEN |
| Manufacturer Street | 6149 N. MEEKER PLACE STE. 110 |
| Manufacturer City | BOISE ID 83713 |
| Manufacturer Country | US |
| Manufacturer Postal | 83713 |
| Manufacturer Phone | 8013682646 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAALT |
| Generic Name | SMALL MENSTRUAL CUP |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | SMALL MENSTRUAL CUP |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAALT, LLC |
| Manufacturer Address | 6149 N. MEEKER PLACE STE. 110 BOISE ID 83713 US 83713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |