MAUDE Adverse Event Report: SURETEX LTD LIFESTYLERS SKYN; LUBRICATED POLYISOPRENE CONDOM

Catalog Number 7412

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Event Description

The customer informed ansell healthcare products, llc that after using a lifestyles polyisoprene lubricated condom she has suffered severe vaginal burning for over a month.

Manufacturer Narrative

(b)(4).Ansell healthcare products llc is submitting this report on behalf of suretex ltd.

• Brand Name: LIFESTYLERS SKYN
• Type of Device: LUBRICATED POLYISOPRENE CONDOM
• Manufacturer (Section D): SURETEX LTD; surat thani ; TH
• Manufacturer (Section G): SURETEX LTD; 331 moo 4 tamboi; khao hua khwia
• Manufacturer Contact: 1635 industrial rd.; dothan, AL 36303 ; 3346152566
• MDR Report Key: 3855869
• MDR Text Key: 17260785
• Report Number: 1019632-2014-00007
• Device Sequence Number: 1
• Product Code: MOL
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 7412
• Device Lot Number: 1210123316
• 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: 05/13/2014
• Distributor Facility Aware Date: 05/08/2013
• Device Age: 18 MO
• Event Location: Other
• Date Report to Manufacturer: 05/13/2014
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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