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

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.

• 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 Key: 3595404
• MDR Text Key: 4066993
• Report Number: 2515444-2014-00001
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 01/14/2014
• 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
• Date Manufacturer Received: 11/26/2013
• 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 Number: 1
• Patient Outcome(s): Disability