MAUDE Adverse Event Report: JOHNSON AND JOHNSON FAMILY OF CONSUMER COMPANIES VISINE FOR CONTACTS (US)

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Rash (2033); Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

This spontaneous report was received from an unspecified pt (unspecified age and gender) reported on self from the united states: (b)(6).The pt's height, weight and medical history were not reported.The pt was treated with visine for contacts (us) (drops, other (opthalmic)) initiated on an unspecified date for drug use for unspecified indication.Concomitant medications were not reported.It was reported that after using visine for contacts, the pt immediately developed a severe rash around eyes which was also trailed with the eye drop down the face.The pt also stated that throat then processed to swell (throat swelling) on an unspecified date.Action taken with visine for contacts was not reported.The pt informed that upon reporting to medical service, the pt was treated for anaphylaxis.Two epipens and a shot of benadryl were given to remove symptoms.The pt recovered from events on an unspecified date.This report was assessed as serious (medically significant).This case, involving the same pt is linked to (b)(6).

• Brand Name: VISINE FOR CONTACTS (US)
• Type of Device: NA
• Manufacturer (Section D): JOHNSON AND JOHNSON FAMILY OF CONSUMER COMPANIES
• Manufacturer Contact: edison rd, bo. ibayo; paranque city NCR 1-700
• MDR Report Key: 3770626
• MDR Text Key: 4378150
• Report Number: 2246407-2013-00872
• Device Sequence Number: 1
• Product Code: LPN
• 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
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 03/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other