MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLREGNORDO; TAMPON, MENSTRUAL, SCENTED

Lot Number 0080243006961057

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

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

There is insufficient information to perform a product investigation.

Event Description

String came out of tampon leaving it inside, had to go to the doctors and have it removed [foreign body in reproductive tract].Pulled tampon string to remove, the string came out of the tampon, leaving it inside [complication of device removal].String came out of the tampon [device breakage].Consumer contacted via e-mail and stated that she pulled the string to remove the tampon and the string came out, leaving the tampon inside.No serious injury was reported.

Event Description

String came out of tampon leaving it inside, had to go to the doctors and have it removed [foreign body in reproductive tract].Pulled tampon string to remove, the string came out of the tampon, leaving it inside / tampon left inside vagina when pulled on string [complication of device removal].String came out of the tampon [device breakage].Consumer contacted via e-mail and stated that she pulled the string to remove the tampon and the string came out, leaving the tampon inside.No serious injury was reported.

Manufacturer Narrative

05-nov-2020 product investigation results: no failure could be identified as a result of the investigation.

Manufacturer Narrative

A product investigation is in progress.

Event Description

String came out of tampon leaving it inside, had to go to the doctors and have it removed [foreign body in reproductive tract].Pulled tampon string to remove, the string came out of the tampon, leaving it inside / tampon left inside vagina when pulled on string [complication of device removal].String came out of the tampon [device breakage].Consumer contacted via e-mail and stated that she pulled the string to remove the tampon and the string came out, leaving the tampon inside.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLPEARLREGNORDO
• Type of Device: TAMPON, MENSTRUAL, SCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn ME 04210
• MDR Report Key: 10543694
• MDR Text Key: 207337224
• Report Number: 1219109-2020-00289
• Device Sequence Number: 1
• Product Code: HIL
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0080243006961057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 08/23/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/29/2020; 11/04/2020
• Supplement Dates FDA Received: 10/28/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR