MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLSUPERNONDO50CT; TAMPON, MENSTRUAL, UNSCENTED

Lot Number 0043243047631212

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

A product investigation is in progress.

Event Description

Absorber was completely lodged into vagina [foreign body in reproductive tract].Discomfort - vagina [vulvovaginal discomfort].Painful - vagina [vulvovaginal pain].Was able to work the absorber out by reaching almost full fist in vagina to retrieve it / this was (painful) [complication of device removal].String completely untied itself from the cotton absorber [device breakage].Consumer contacted via e-mail and stated that the string completely untied itself from the cotton absorber of the tampon.No serious injury was reported.

Manufacturer Narrative

(b)(6) 2020 product investigation results: no failure could be identified as a result of the investigation.

Event Description

Absorber was completely lodged into vagina [foreign body in reproductive tract] discomfort - vagina [vulvovaginal discomfort] painful - vagina [vulvovaginal pain] was able to work the absorber out by reaching almost full fist in vagina to retrieve it / this was (painful) [complication of device removal] string completely untied itself from the cotton absorber [device breakage] case description: consumer contacted via e-mail and stated that the string completely untied itself from the cotton absorber of the tampon.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLSUPERNONDO50CT
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn, me
• MDR Report Key: 10057620
• MDR Text Key: 191560709
• Report Number: 1219109-2020-00084
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• PMA/PMN Number: K081555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0043243047631212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1