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 BLUE manufactured by Saalt, Llc.
[183550439]
Customer had used her saalt cup for 4 periods before the stem broke off during removal on (b)(6) 2019. Customer went to urgent care to have cup removed as she could not reach the base of the cup without using the stem to remove the cup. The doctor disgarded the cup at the hospital. Saalt provided a refund for the purchase of the cup and removal tips if she chooses to use a menstrual cup in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20042 |
| MDR Report Key | 9720750 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2019-10-29 |
| 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 BLUE |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | SMALL BLUE |
| 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 | 2020-02-18 |