MAUDE Adverse Event Report: OB SUPER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Swollen Glands (2092); Complaint, Ill-Defined (2331)

Event Date 10/10/2014

Event Type  Injury  

Event Description

While using ob tampons, i developed extreme swollen glands in the inguinal and perineal area, and felt extremely unwell.For the week following the first day of my period, i felt extremely tired and run down, at times wondering if something was seriously wrong with me.This intensified over a number of cycles.At first, i attributed it to my period, but on a whim, i decided to use a tampon mid-cycle to see what would happen.Sure enough, within 8 hours, swelling had begun.After doing some online research and finding a discussion of the possible issues with certain brands of tampons, i switched to another brand (natracare).I have not had issues with fatigue, pain, or swelling since.

• Brand Name: OB SUPER
• Type of Device: OB SUPER
• MDR Report Key: 4672350
• MDR Text Key: 5607029
• Report Number: MW5041990
• Device Sequence Number: 1
• Product Code: HEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/03/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: Not provided
• Patient Sequence Number: 1
• Treatment: IRON; MULTI-VITAMIN; ASTRAGALUS
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Weight: 61