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 PINK manufactured by Saalt, Llc.
[183553417]
Customer reached out to us on (b)(6) 2019 letting us know she had tried the saalt cup for the first time. She stated that a friend had told her to remove the stem from the cup prior to use, so she did so before ever using the cup. When she went to remove the cup, she had difficulty removing the cup and ended up seeking medical help to remove the cup. The customer noted that they watched some (b)(6) videos, blogs, and visited our website to look for tips. Doctor who removed cup also discarded the cup. We offered additional removal tips after being notified and offered a refund for the purchase of the cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20011 |
| MDR Report Key | 9720675 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-24 |
| 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 PL. 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 PINK |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | SMALL 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 PLACE STE. 110 BOISE ID 83713 US 83713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |