MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL BRAZIL ALL-FLEX ARCHING SPRING DIAPHRAGM (SILICONE

Device Problem Fitting Problem (2183)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

This spontaneous report received from a pt, via (b)(6), the united states (local id number (b)(6)).The pt's height, weight, and medical history were unk.The pt was prescribed an all-flex arcing spring diaphragm silicone on an unspecified date.Concomitant medication(s) were not reported.On an unk date, the pt experienced difficultly in removing her diaphragm.The pt sent an email to the medical info group in (b)(6) stating that she has "difficulty removing her ortho diaphragm" and that her "fingers are not long enough".She inquired about identifying a "tool available to hook onto the rim so that she could pull it out".She indicated that she had tried to find such a tool on the web to purchase, but was unsuccessful.The pt outcome was unk for experiencing difficulty in removing the diaphragm.This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)).This report was non reportable (malfunction).

Manufacturer Narrative

The lot number was not provided.

• Brand Name: ALL-FLEX ARCHING SPRING DIAPHRAGM (SILICONE
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL BRAZIL; sao jose dos campos ; BR
• Manufacturer Contact: 1125 trenton-harbourton rd; titusville, NJ 08560 ; 2153257722
• MDR Report Key: 3770339
• MDR Text Key: 16450482
• Report Number: 2242843-2014-00186
• 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: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2014
• Distributor Facility Aware Date: 03/17/2014
• Date Report to Manufacturer: 03/14/2014
• Date Manufacturer Received: 03/14/2014
• 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