MAUDE Adverse Event Report: LIFESTYLES SKYN; LUBRICATED POLYISOPRENE CONDOMS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Type  Injury  

Event Description

Pediatrician saw underage female for vaginal redness and swelling after using lifestyles skyn condom.

Manufacturer Narrative

(b)(4).Ansell healthcare products, llc is submitting this report, factory unk at this time.

• Brand Name: LIFESTYLES SKYN
• Type of Device: LUBRICATED POLYISOPRENE CONDOMS
• Manufacturer Contact: tammy mcgriff ; 1635 industrial rd.; dothan, AL 36303 ; 3346152566
• MDR Report Key: 3608898
• MDR Text Key: 16085232
• Report Number: 1019632-2014-00001
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2014
• Distributor Facility Aware Date: 01/16/2014
• Event Location: Other
• Date Manufacturer Received: 01/17/2014
• 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): Other