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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLACTVPEARLACTVREGNOR; TAMPON, MENSTRUAL, SCENTED
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TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLACTVPEARLACTVREGNOR; TAMPON, MENSTRUAL, SCENTED Back to Search Results
Lot Number 7068208000V2090 3171747
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Manufacturer Narrative
A product investigation is in progress.
 
Event Description
Chunk of cotton came right out of tampon, may be stuff still inside - vagina [foreign body in reproductive tract].Took the tampon out, noticed a chunk of the cotton came right out [complication of device removal].Chunk of cotton came right out of tampon [device breakage].Consumer contacted via e-mail and stated that when she took the tampon out she noticed a chunk of the cotton came right out.No serious injury was reported.
 
Event Description
Chunk of cotton came right out of tampon, may be stuff still inside - vagina [foreign body in reproductive tract].Took the tampon out, noticed a chunk of the cotton came right out [complication of device removal].Chunk of cotton came right out of tampon [device breakage].Consumer contacted via e-mail and stated that when she took the tampon out she noticed a chunk of the cotton came right out.No serious injury was reported.
 
Manufacturer Narrative
(b)(6) 2020 product investigation results: no failure could be identified as a result of the investigation.
 
Manufacturer Narrative
Correction 30-sep-2020: product was updated to tampax tampons pearl active regular-normal.
 
Event Description
Chunk of cotton came right out of tampon, may be stuff still inside - vagina [foreign body in reproductive tract].Took the tampon out, noticed a chunk of the cotton came right out [complication of device removal].Chunk of cotton came right out of tampon [device breakage].Consumer contacted via e-mail and stated that when she took the tampon out she noticed a chunk of the cotton came right out.No serious injury was reported.
 
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Brand Name
TAMPAXTAMPONSPEARLACTVPEARLACTVREGNOR
Type of Device
TAMPON, MENSTRUAL, SCENTED
Manufacturer (Section D)
TAMBRANDS MANUFACTURING, INC
2879 hotel rd
auburn ME 04210
MDR Report Key10296985
MDR Text Key199538764
Report Number1219109-2020-00183
Device Sequence Number1
Product Code HIL
Combination Product (y/n)N
PMA/PMN Number
K131543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number7068208000V2090 3171747
Was Device Available for Evaluation? No
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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