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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT; TAMPON, MENSTRUAL, UNSCENTED - HEB
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TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT; TAMPON, MENSTRUAL, UNSCENTED - HEB Back to Search Results
Lot Number 3063243064W
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Strings just started falling off of the cotton part - tampon [device breakage].Case narrative: consumer reported via email that the strings started falling off when she opened them.No injury was reported.
 
Manufacturer Narrative
Product investigation is in progress.
 
Event Description
Strings just started falling off of the cotton part - tampon [device breakage].Case narrative: consumer reported via email that the strings started falling off when she opened them.No injury was reported.
 
Manufacturer Narrative
No failure could be identified as a result of the investigation.
 
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Brand Name
TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT
Type of Device
TAMPON, MENSTRUAL, UNSCENTED - HEB
Manufacturer (Section D)
TAMBRANDS MANUFACTURING, INC
2879 hotel rd
auburn 04210
Manufacturer (Section G)
TAMBRANDS MANUFACTURING, INC
2879 hotel rd
auburn 04210
Manufacturer Contact
manager affairs,feminine care
winton hill business center b
6280 center hill avenue
cincinnati 45224
MDR Report Key18383138
MDR Text Key331207504
Report Number1219109-2023-00444
Device Sequence Number1
Product Code HEB
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K110669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number3063243064W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2023
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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