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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT UNSCENTED TAMPONS, SUPER PLUS, 18 CT; MENSTRUAL TAMPON
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PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT UNSCENTED TAMPONS, SUPER PLUS, 18 CT; MENSTRUAL TAMPON Back to Search Results
Model Number X08111JO
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Toxic Shock Syndrome (2108)
Event Date 12/31/2015
Event Type  Injury  
Event Description
Fda contacted edgewell personal care on march 9, 2016, to inform edgewell that the agency has received four reports (mw5059966, mw5059967, mw5059968 and mw5060650) concerning adverse events involving playtex sport tampons.The reports indicate that four young women have been hospitalized at a single hospital since the beginning of the year with (b)(4).
 
Manufacturer Narrative
On july 1, the (b)(6) department of health ((b)(6)) provided date codes and product descriptions for three different absorbencies, but added that at least one of them was not in use at the time of the event.Mw5059966.
 
Event Description
Fda contacted edgewell personal care on march 9, 2016, to inform edgewell that the agency has received four reports (mw5059966, mw5059967, mw5059968 and mw5060650) concerning adverse events involving playtex sport tampons.The reports indicate that four young women have been hospitalized at a single hospital since the beginning of the year with (b)(4).
 
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Brand Name
PLAYTEX SPORT UNSCENTED TAMPONS, SUPER PLUS, 18 CT
Type of Device
MENSTRUAL TAMPON
Manufacturer (Section D)
PLAYTEX MANUFACTURING, INC.
805 walker rd
dover DE 19904
Manufacturer (Section G)
PLAYTEX MANUFACTURING, INC.
805 walker rd
dover DE 19904
Manufacturer Contact
gale lydic
185 saulsbury rd
dover, DE 19904
3026786429
MDR Report Key5831532
MDR Text Key160398395
Report Number0002515444-2016-00003
Device Sequence Number1
Product Code HEB
UDI-Device Identifier7830008111
UDI-Public78300-08111
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 07/11/2016
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? No
Device Operator Lay User/Patient
Device Model NumberX08111JO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age1 YR
Initial Date Manufacturer Received 03/09/2015
Initial Date FDA Received07/28/2016
Supplement Dates Manufacturer Received03/09/2016
Supplement Dates FDA Received07/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2015
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 Outcome(s) Hospitalization; Other;
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