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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON O.B. ORIGINAL TAMPONS; O.B. TAMPONS

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JOHNSON & JOHNSON O.B. ORIGINAL TAMPONS; O.B. TAMPONS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hair Loss (1877); Rash (2033); Discomfort (2330); Disability (2371)
Event Date 01/01/1991
Event Type  Injury  
Event Description
An o.B.Tampon user called to report she was diagnosed with tss in 1991 and never treated.At the time of her diagnosis she was using o.B.Tampons.User states she had numerous diagnoses and treatments for various ailments over the years and has been disabled for 14 years.She has a rash on her face, is losing her hair, and has lung and intestinal issues as well as vaginal discomfort.
 
Manufacturer Narrative
Energizer personal care, llc is submitting this report only because an event meeting the requirements of 21 cfr 803 may have occurred.This does not mean that an energizer product malfunctioned or that an energizer product was, in fact, associated with an actual consumer injury.Consequently, the report must not be construed as an admission of any kind by energizer.
 
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Brand Name
O.B. ORIGINAL TAMPONS
Type of Device
O.B. TAMPONS
Manufacturer (Section D)
JOHNSON & JOHNSON
montreal
CA 
Manufacturer Contact
jennifer rempe
6 research drive
shelton, CT 06484
MDR Report Key3595404
MDR Text Key4066993
Report Number2515444-2014-00001
Device Sequence Number1
Product Code HIL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/14/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/26/2013
Initial Date FDA Received01/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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