MAUDE Adverse Event Report: THINX, INC. THINX; PAD, MENSTRUAL, REUSABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to 21 c.F.R.Part 803.This report does not reflect a conclusion or admission by thinx, or its employees, that the product caused or contributed to the event described in this report, or that the thinx product failed to meet its performance specifications or otherwise perform as intended.This initial report is based on information which thinx received from the consumer; but thinx is continuing to investigate, and the information has not been fully verified.The consumer alleges serious injuries; however, no details regarding the reported event have been provided and attempts to obtain additional information continue.No lot information was provided with the complaint; however, manufacturing records are being reviewed based on date ranges.If information is obtained that was not available for the initial report, a supplemental report will be filed as appropriate.

Event Description

Consumer alleged infertility issues.No further information provided.

Manufacturer Narrative

No further information is available regarding the alleged event.The investigation concluded there were no product defects or nonconformances that may have caused or contributed to the reported event.The device and its components have been evaluated and determined to be safe for their intended use.Our investigation revealed no basis to conclude the device could have caused or contributed to the reported event.

• Brand Name: THINX
• Type of Device: PAD, MENSTRUAL, REUSABLE
• Manufacturer (Section D): THINX, INC.; 100 broadway; floor 9; new york NY 10005
• Manufacturer (Section G): MAS INTIMATES; lot 56, zone a; biyagama export processing zon; malwana, biyagama 11650 ; CE 11650
• Manufacturer Contact: jenna groves ; 100 broadway; floor 9; new york, NY 10005 ; 2144229354
• MDR Report Key: 16562604
• MDR Text Key: 311472699
• Report Number: 3013407123-2023-00006
• Device Sequence Number: 1
• Product Code: NUQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Female