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 N/A manufactured by Saalt, Llc.
[183551958]
Saalt was made aware of the event via (b)(6) reviews. Customer described struggling to remove their cup, then going to urgent care to seek assistance having it removed. Urgent care doctors were unsuccessful and referred her to another medical professional. Saalt reached out to the customer requesting that she contact us via email/messaging. The customer did not, and as she contacted us on (b)(6) review platform, we had no way of contacting her directly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20032 |
| MDR Report Key | 9720735 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-16 |
| 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. SUITE 110 |
| Manufacturer City | BOISE, ID |
| Manufacturer Country | US |
| Manufacturer Phone | 3682646 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAALT |
| Generic Name | N/A |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| 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. BOISE, ID US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |