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 REGULAR PINK manufactured by Saalt, Llc.
[183551509]
Customer was first a time cup user and panicked when she was unable to quickly and easily remove her cup. She reached out to saalt via email for advice on removal. Saalt sent many resources advising her the best ways to remove her cup. She was still unable to get the cup out on her own. The customer ultimately sought medical intervention from her obgyn, and her physician was able to remove the cup using scissors and forceps. The cup was discarded at the clinic. The customer was given a refund of the purchase of her cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20018 |
| MDR Report Key | 9720705 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-06-14 |
| 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 PL SUITE 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 | REGULAR PINK MENSTRUAL CUP |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | REGULAR PINK |
| 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 PL SUITE 110 BOISE ID 83713 US 83713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |