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 SMALL PINK manufactured by Saalt, Llc.
[188993429]
Customer attempted to use her cup for the first time, and the following morning of (b)(6) 2019 struggled to remove her cup. She referred to our instructions for removal tips and still could not remove her cup. Her cup had been inserted for 12 hours prior to her removal attempts. She began to panic and went to the minor injuries unit. A nurse was able to successfully remove the cup. Customer was given a refund for her purchase.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-00005 |
| MDR Report Key | 9644666 |
| Report Source | CONSUMER |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-08-27 |
| 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 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 | SMALL PINK |
| Product Code | HHE |
| Date Received | 2020-01-29 |
| Model Number | SMALL PINK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-29 |