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

Model Number 75 MM

Device Problem Malfunction (2409)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  malfunction  

Event Description

This spontaneous pregnancy report was received from a female patient of unspecified age (reporting on herself) from the united states (local case identification number (b)(6)).Initial information was processed with additional information received from central complaint vigilance usa on (b)(6) 2014.The patient's weight, height and medical history were not reported.It was not reported if the patient had experienced prior pregnancies.The date of the patient's last menstrual period and expected delivery date were both unspecified.The patient was prescribed the all-flex arcing spring diaphragm (silicone) on an unspecified date.Concomitant medications were not reported.On an unspecified date, the patient experienced a device issue and pregnancy with contraceptive device.The patient reported she was pregnant (date of pregnancy was not provided).The patient did not clarify if the pregnancy was planned or unplanned.The patient also reported after her pregnancy (reported as after childbirth), the diaphragm size decreased from 75 to 70 (device issue).The patient recovered from the pregnancy with contraceptive device on an unknown date and outcome was unknown for the device issue.This report is associated with product quality complaint (pqc) reference number (b)(4).This report was serious (malfunction).

Manufacturer Narrative

The patient did not provide contact information.The patient did not provide the diaphragm for evaluation and during the call did not provide a lot number.

• 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: 4353483
• MDR Text Key: 20453370
• Report Number: 2242843-2014-01214
• Device Sequence Number: 1
• Product Code: HDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 75 MM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Distributor Facility Aware Date: 12/10/2014
• Event Location: Home
• Date Report to Manufacturer: 12/10/2014
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other