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 CUP REGULAR BLUE - DUO PACK manufactured by Saalt, Llc.
[183552140]
The customer contacted saalt after having visited the urgent care to have her cup removed. After additional contact, the customer noted that this was her first cycle and she had used the small cup with success several times. On this particular occasion the customer inserted the regular size cup prior to going to bed. In the morning she tried many different methods to remove the device, including inserting a spoon to attempt to remove the cup. She waited a couple of hours before trying again. When she wasn't able to remove the device at that time she decided to go to urgent care where the doctor was able to get it out. The customer stated that the doctor noted that her cervix is quite high, which made the cup difficult to reach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014276660-2020-20015 |
| MDR Report Key | 9720689 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-05-20 |
| 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 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 CUP |
| Generic Name | DUO PACK |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | REGULAR BLUE - DUO PACK |
| 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 | 2020-02-18 |