MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE); HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES

Lot Number A19FU1

Device Problems Fitting Problem (2183); Defective Device (2588)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Event Description

This spontaneous report received from a patient concerns a (b)(6) year old white female (reporting on herself) from the united states (local id number (b)(6)).The patient's concurrent conditions included: abstains from alcohol, attention deficit hyperactivity disorder (adhd), depression, high blood pressure and non smoker.The patient's weight was (b)(6) pounds and height was (b)(6) inches.Other medical history included: no known allergies, no known drug allergies and no drug abuse/illicit drug use.The patient was prescribed an all-flex arcing spring diaphragm (silicone, lot number a19fu1, expiration 05/01/2016) on an unspecified date.Concomitant medications included: amlodipine besilate for high blood pressure, hydrochlorothiazide w/losartan for high blood pressure, paroxetine hydrochloride for depression and adderall (amphetamine and dextroamphetamine) for adhd.In (b)(6) 2013, the patient experienced a defect in diaphragm and difficulty in inserting diaphragm and in (b)(6) 2014, the patient experienced a urinary tract infections (uti).The patient began using the all-flex arcing spring diaphragm about 10 years ago.She began using the all-flex arcing spring diaphragm silicone in (b)(6) 2013.She stated that in the beginning of using the new diaphragm that she felt something was wrong with it because it didn't fit right, clarified as she had a lot of trouble getting the diaphragm in (difficulty in inserting diaphragm).She reported developing uti about three (3) weeks ago ((b)(6) 2014).The patient also reported trying the diaphragm during her menstrual cycle and blood leaked right through the diaphragm and the rim seems to be bent.No additional information reported.The diaphragm is available for retrieval at patient's home.The patient has not recovered from the defect in diaphragm and difficulty in inserting diaphragm and the outcome was unknown for the uti.This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)).This report was serious (malfunction).

Manufacturer Narrative

The diaphragm is available for retrieval at patient's home.

• Brand Name: ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)
• Type of Device: HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB); sao jose dos campos ; BR
• Manufacturer Contact: 1125 trenton-harbourton rd.; titusville, NJ 08560 ; 2153257722
• MDR Report Key: 3799647
• MDR Text Key: 21804458
• Report Number: 2242843-2014-00221
• Device Sequence Number: 1
• Product Code: HDW
• 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,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2016
• Device Lot Number: A19FU1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2014
• Distributor Facility Aware Date: 04/02/2014
• Event Location: Home
• Date Report to Manufacturer: 04/02/2014
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 59