MAUDE Adverse Event Report: LIFESTYLES

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

(b)(4).- ansell healthcare products llc is submitting this report on behalf of unk mfr.

Event Description

The customer informed ansell healthcare products, llc that after using a lifestyles condom that contained spermicide nonoxynol-9 he received a severe skin burn.

• Brand Name: LIFESTYLES
• Type of Device: UNK
• Manufacturer Contact: 1635 industrial rd.; dothan, AL 36303 ; 3346152566
• MDR Report Key: 4309898
• MDR Text Key: 22226241
• Report Number: 1019632-2014-00016
• Device Sequence Number: 1
• Product Code: LTZ
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• 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: 12/04/2014
• Distributor Facility Aware Date: 12/02/2014
• Event Location: Other
• Date Manufacturer Received: 12/02/2014
• 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