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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLREGNORDO; TAMPON, MENSTRUAL, SCENTED
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TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLREGNORDO; TAMPON, MENSTRUAL, SCENTED Back to Search Results
Lot Number 0210243048W, 0237243048W
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
A product investigation is in progress.
 
Event Description
Tampon fell apart and a piece of cotton remained inserted [foreign body in reproductive tract].Tampon fell apart [device breakage].Case description: consumer contacted via e-mail and stated that twice after she used a tampon, it fell apart and a piece of cotton remained inserted.No serious injury was reported.
 
Manufacturer Narrative
04-dec-2020 product investigation results: no failure could be identified as a result of the investigation.
 
Event Description
Tampon fell apart and a piece of cotton remained inserted [foreign body in reproductive tract] tampon fell apart [device breakage] consumer contacted via e-mail and stated that twice after she used a tampon, it fell apart and a piece of cotton remained inserted.No serious injury was reported.
 
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Brand Name
TAMPAXTAMPONSPEARLPEARLREGNORDO
Type of Device
TAMPON, MENSTRUAL, SCENTED
Manufacturer (Section D)
TAMBRANDS MANUFACTURING, INC
2879 hotel rd
auburn ME 04210
MDR Report Key11029210
MDR Text Key222097286
Report Number1219109-2020-00416
Device Sequence Number1
Product Code HIL
Combination Product (y/n)N
PMA/PMN Number
K081555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number0210243048W, 0237243048W
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/03/2020
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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