MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-29 for SAALT REGULAR manufactured by Saalt.
[188993171]
Customer reached out to us on 12/21/2018 letting us know she inserted her cup comfortably and wore it while sleeping. Once it was time to remove the cup in the morning, she was unable to reach the base of the cup for removal. She tried for many hours to remove the cup without success. She ended up visiting her local doctor and the cup was removed by a medical professional. The cup was inserted for a total of 19 hours and she reported returning to the doctor at a later date due to an infection she believes was caused by her removal attempts. Saalt has followed up to attempt to gain more information and refund the customer without any response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20004 |
| MDR Report Key | 9644669 |
| Report Source | CONSUMER |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-28 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2020-01-29 |
| 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 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 |
| Product Code | HHE |
| Date Received | 2020-01-29 |
| Model Number | REGULAR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAALT |
| Manufacturer Address | 6149 N, MEEKER PLACE STE. 110 BOISE, ID ID 83713 US 83713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |