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 BLUE manufactured by Saalt, Llc.
[183566291]
Customer used cup for the first time and easily removed it after an hour. Customer reinserted her cup then attempted removal for a second time 5 hours later. After utilizing multiple saalt resources as well as other websites and (b)(6) channels, customer still could not reach and remove her cup. Customer attempted removal for 3 hours prior to going to urgent care. Customer says she could only bear the cup down enough to reach the tip of the stem. The doctor removed her cup and returned the cup to the customer. Saalt followed up with additional removal resources and offered a refund for the purchase of the cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20040 |
| MDR Report Key | 9720741 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-10-22 |
| Date Mfgr Received | 2019-10-22 |
| 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 | REGULAR BLUE |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | REGULAR 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 | 1. Required No Informationntervention | 2020-02-18 |