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 manufactured by Saalt, Llc.
[183551428]
Customer posted on our saalt (b)(6) group that she went to the doctor to have her cup removed, and we asked her to email us more information. Customer stated that her cup had been inserted for 10 hours when she first attempted removal, but did not state how long it had been in when removal was achieved. When asked what resources she used to help her remove her cup on her own, she stated "all of the above," (referring to instructions, saalt cup academy, (b)(6) videos, contacting saalt) however, we have no record of her contacting saalt prior to seeking medical care. The only information she offered as to what techniques she used to try to remove her cup was that she tried to reach the base. We offered and sent a replacement cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20055 |
| MDR Report Key | 9720800 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3682646 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAALT |
| Generic Name | SMALL |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | SMALL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |