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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAALT, LLC SAALT; SMALL BLUSH

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SAALT, LLC SAALT; SMALL BLUSH Back to Search Results
Model Number SMALL BLUSH
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/14/2021
Event Type  Injury  
Event Description
Customer posted in saalt's (b)(6) group describing that their iud came out while removing their cup.Saalt commented on the customer's (b)(6) post and asked them to email us directly.They emailed us directly on 1/14/2021 and we requested additional information about their experience.Customer responded with the information requested and provided their dob, phone number, address, order number, and a photo of their cup.They said that their cup strings were cut to 2 inches and their medical provider said they would be fine using the cup and iud together.She said she always breaks the seal of the cup during removal.Instructions for use (ifu) states to consult your physician before using your cup with an iud.We have since updated our instructions to add the language "be sure to break the seal before removing your saalt cup to avoid dislodging your iud.".
 
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Brand Name
SAALT
Type of Device
SMALL BLUSH
Manufacturer (Section D)
SAALT, LLC
6148 n discovery way
ste. 175
boise ID 83713
Manufacturer Contact
6148 n discovery way
ste. 175
boise, ID 83713
MDR Report Key11209249
MDR Text Key228166225
Report Number3014276660-2021-02711
Device Sequence Number1
Product Code HHE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSMALL BLUSH
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received01/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age23 YR
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