|
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 polyp which required removal.No further information provided.
|
|
Manufacturer Narrative
|
Consumer further reported the cause of the polyp was not determined.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.
|
|
Event Description
|
Consumer further reported a 3.5cm polyp, allegedly acting as a natural iud, was removed in an outpatient clinic (b)(6) 2022. the cause of the polyp was not determined. consumer reported bleeding, extreme discomfort, and unspecified trauma as a result.
|
|
Search Alerts/Recalls
|
|
|