MAUDE Adverse Event Report:; NONE

Device Problem Improper Chemical Reaction (2952)

Patient Problems Pain (1994); Burning Sensation (2146); Tingling (2171)

Event Date 02/25/2014

Event Type  Injury  

Event Description

End-user reports that he accidently used product while masturbating and immediately felt tingling which progressed to burning.States he is embarrassed and did not wish to give last name or address.After masturbating; washed but continues to feel some tingling and minor burning and now has a priapism.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.It is reported that end-user has not seen a physician.Covatec's customer service nurse are commended washing effected site again to remove any residual ointment, and if end-user continues to experience symptoms, especially priapism, end-user should contact his health care provider.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional info becomes available, a follow-up report will be submitted reported to the fda.Third party manufacturer: (b)(4).Convatec will continue to track and monitor such complaints according to it's complaint handling and capa procedures.

• Type of Device: NONE
• Manufacturer Contact: matthew walenciak, assoc director ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042287
• MDR Report Key: 3717112
• MDR Text Key: 4331219
• Report Number: 2243969-2014-00096
• Device Sequence Number: 1
• Product Code: KOY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• 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: 03/20/2014
• 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
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention