MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-30 for SAALT SAALT CUP manufactured by Saalt, Llc.
[177180836]
Customer contacted saalt after having gone to the hospital to have her cup removed. After further email contact, the customer stated that she was using her saalt cup for the first time and felt that she could not remove the cup on her own. She stated that she had worn it to bed and when she woke up it was too high to reach. After waiting an hour and trying again, felt the need to go to the emergency room to have it removed. The doctor in the er was able to remove the cup and discarded it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20014 |
| MDR Report Key | 9649586 |
| Report Source | CONSUMER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-05-12 |
| Date Added to Maude | 2020-01-30 |
| 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 | SAALT MENSTRUAL CUP |
| Product Code | HHE |
| Date Received | 2020-01-30 |
| Model Number | SAALT CUP |
| 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 PL SUITE 110 BOISE ID 83713 US 83713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |