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

Catalog Number 70 MM

Device Problem Fitting Problem (2183)

Patient Problem Discomfort (2330)

Event Date 02/01/2014

Event Type  Injury  

Event Description

This spontaneous report received from a health professional (medical assistant) concerns a (b)(6) female from the united states (local id number(b)(6)).The patient's concurrent condition included: social drinker.The patient's medical history included: non smoker.Other medical history included: no known allergies, no known drug allergies and no drug abuse/illicit drug use.The patient's weight was (b)(6) and height was (b)(6).The patient was prescribed an all-flex arcing spring diaphragm silicone (lot number ao4fu1) on an unspecified date in (b)(6) 2014 for prevention of pregnancy.Concomitant medications were not reported.In (b)(6) 2014, the patient experienced contraceptive diaphragm uncomfortable.The patient reported the ring on her diaphragm was rigid and stiffer than the fitting kit and it made her uncomfortable.The patient stopped using the diaphragm in (b)(6) 2014.The reporter provided the lot number, but the expiration date was not visible on the package.The diaphragm is available at the office.The patient outcome was unknown for the contraceptive diaphragm uncomfortable.This report was associated with a product quality complaint (pqc) number (pqc number (b)(4) ).This report was non reportable as no serious injury, death, or malfunction occurred.Additional information was received from the (b)(6) on (b)(6) 2014.The case report has been reassessed to serious (potential serious injury).The lot number for the all-flex arcing spring diaphragm silicone (70mm) was amended to a04fu1 (previously reported as lot number ao4fu1).The reporter was contacted for clarification of the issues.The reporter stated that the out ring (part that holds it in place) of the diaphragm was rigid and stiffer than the fitting kit.The reporter was communicating on behalf of a patient.The reporter also clarified that the plastic container/case that stores the diaphragm only had the lot number but no expiration date was printed there.A field sample is available for return in case the site wants it.This report was serious (reportable serious injury).

Manufacturer Narrative

The lot number was reported.

• Brand Name: ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)
• Type of Device: HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES
• Manufacturer (Section D): JOHNSON AND JOHNSON MEDICAL BRAZIL (JJMB); sao jose dos campos
• Manufacturer Contact: 1125 trenton-harbourton rd.; titusville, NJ 08560 ; 2153257722
• MDR Report Key: 3750752
• MDR Text Key: 4464773
• Report Number: 2242843-2014-00156
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 70 MM
• Device Lot Number: A04FU1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2014
• Distributor Facility Aware Date: 02/25/2014
• Date Report to Manufacturer: 02/25/2014
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 33 YR
• Patient Weight: 61