MAUDE Adverse Event Report: SERENITY TMT - PELVIC FLOOR MASSAGE AND TRIGGER POINT TOOL-VAGINAL ; MASSAGER, THERAPEUTIC, MANUAL

Device Problems Scratched Material (3020); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

I have been in pelvic floor pt and was recommend the serenity tmt - pelvic floor massage and trigger point tool-vaginal product for use at home from (b)(4).Link to product (b)(4).I ordered one initially on (b)(6).After only a few uses it began splintering.I always kept in the carry pouch in a drawer and never threw it around or smashed it, but yet i pulled it out to use and it was covered in splintered lines and had some very sharp and jagged edges.Of course i couldn't use it like this given where the device is inserted, so i ordered another one.I always washed it with an ammonia-free soap and let it air dry, per the instructions.Finally i was shipped a new one (b)(6).I used that one a single time and then pulled it out of the bag and found it had the same splintering effect happening.There were no sharp edges so i used it one or two more times, but then a sharp edge emerged and i deemed it unusable.I made my way to another store where they have pelvic floor pt devices and spoke with them about what was happening.They told me a similar, essentially identical device, and assured me this wouldn't splinter because it was made out of high quality materials.So far i have not had the same issue with this other brands, leading me to believe that (b)(4) product is faulty and frankly, extremely dangerous.My pt told me today that she has seen other pts with the same device have the same exact thing happen to them.I have emailed (b)(4) about this and they continue to insist that i am using the incorrect soap to wash the device.Their website says to use with no ammonia, i do not have any ammonia based soaps in my home and only wash it with gentle hand soap and air dry per the instructions.My pt told me that (b)(4) reached out to her as well after i emailed them her contact info and she said they are also insisting to her that the quality of the device is not compromised and that everybody is using dangerous soap.It is clear that the quality of the device is not safe, especially given that this device is for use inside of the vagina yet presents with sharp edges in the material after only a use or two.I never had a medical issue because i noticed the splintering and the hard/sharp edges, but i can only imagine the medical trauma i would have experienced had i inserted this into my vagina.I am really frustrated that (b)(4) continues to sell this device without any acknowledgement that it is clearly a dangerous product.(b)(4).Fda safety report id# (b)(4).

• Brand Name: SERENITY TMT - PELVIC FLOOR MASSAGE AND TRIGGER POINT TOOL-VAGINAL
• Type of Device: MASSAGER, THERAPEUTIC, MANUAL
• MDR Report Key: 9750812
• MDR Text Key: 181388735
• Report Number: MW5093255
• Device Sequence Number: 2
• Product Code: LYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 91