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

Lot Number B78CU1

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 report received from a pt concerns a (b)(6) female from the united states (local id number (b)(6)).The pt's concurrent condition included: abstains from alcohol, allergies (dust/cats) and hay fever.The pt's weight was (b)(6) and height was (b)(6).The pt also has no drug abuse/illicit drug use.The pt was prescribed an all-flex arcing spring diaphragm (silicone, lot number b78cu1, expiration august 2013) for birth control in 1992.Concomitant medications included acetylsalicylic acid for blood clot, fexofenadine for allergies, multivitamins for vitamin supplement, calcium for vitamin supplement, and omega-3 marine triglycerides for vitamin supplement.On an unk date, the pt experienced weight increase, became pregnant and had intentional weight loss.The pt began ortho all-flex arcing spring diaphragm in 1992.The pt reported her weight "ballooned" on an unspecified date while using the diaphragm.The pt reported she became pregnant while using the diaphragm in 2001.The pt reported she believed the diaphragm did not fit properly after her weight gain and she never got re-measured, resulting in her becoming pregnant.The pt reported for an unk reason that she stopped using the ortho all-flex arcing spring diaphragm in 2011 and switched to the generic yaz (drospirenone/ethinyl estradiol) oral birth control pill.The pt reported developing a blood clot in her leg in 2013.She was hospitalized and treated with warfarin for six months.She discontinued the generic yaz (drospirenone/ethinyl estradiol) oral contraceptive pill.The pt reported an intentional weight loss in 2013.The pt reported being diagnosed with factor 5 disorder in (b)(6) 2013.The pt began using the ortho all-flex arcing spring diaphragm again in april 2013.The pt outcome was unk for the weight increase, becoming pregnant and intentional weight loss.This report is associated with a product quality complaint (pqc) reference number (b)(4).This report was serious (serious injury).

Manufacturer Narrative

The pt provided a lot number and expiration number for eval.

• Brand Name: ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)
• 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: 4663620
• MDR Text Key: 16075694
• Report Number: 2242843-2015-00319
• 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: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2013
• Device Lot Number: B78CU1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2015
• Distributor Facility Aware Date: 03/26/2015
• Event Location: Home
• Date Report to Manufacturer: 03/26/2015
• Date Manufacturer Received: 03/26/2015
• 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
• Treatment: TRIGLYCERIDES) VITAMIN 1 DAILY; MULTIVITAMINS 1 DAILY; CALCIUM SUPPLEMENTATION 1 DAILY; XE OMEGA ESSENTIAL OIL COMPLEX (OMEGA-3 MARINE; ASPIRIN (ACETYLSALICYLIC ACID) 1 DAILY ORAL; FEXOFENADINE 1 DAILY
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 75