MAUDE Adverse Event Report: RECKITT BENCKISER DUREX PLEASUREMAX; CONDOM

Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Venereal Disease (2071)
Date of Event	09/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident.The patient did specify the variety of durex that was used as durex pleasuremax.The patient neither provides the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The product labelling also states that "please read the leaflet inside this pack carefully, especially if you are using condoms for anal or oral sex.No method of contraception can give you 100% protection against pregnancy, hiv or sexually transmitted infections.Use a condom only once." the company's assessment is serious with a relatedness of possible.
Event or Problem Description
Case description: initial report, received date: 18-jan-2017.Received from consumer relations, country: (b)(6), (b)(4).Medical device: durex settebello classic (product not marketed in usa) batch no and expiry date: not provided.Medical device: durex pleasuremax.(product also marketed in usa).Batch no and expiry date: not provided.Case reference number (b)(4) is a report sent by a consumer which refers to a male age unknown.The case was received from (b)(6).It was reported that on an unknown date, a male patient age unknown used durex settebello classic and durex pleasuremax.He said that the events happened around the end of (b)(6).He had been using durex for longer than 10 years, more or less all of them.When the first episode happened, he was wearing a durex settebello classic, it broke almost at the end of the intercourse right before ejaculating.He said he had another episode happened with pleasure max, it broke during intercourse but without ejaculation at all, he had to do the (b)(6) test after three months, he got the result on (b)(6) 2017, and it was (b)(6).He said he changed brand because due to this two episodes, he was on treatment for huge (b)(6).The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.

• Brand Name: DUREX PLEASUREMAX
• Common Device Name: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER; 399 interpace parkway; parsippany NJ 07054
• MDR Report Key: 6305811
• Report Number: 3003071219-2017-00002
• Device Sequence Number: 817539
• Product Code: HIS
• UDI-Device Identifier: 00302340301787
• UDI-Public: 00302340301787
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K040185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Speech Therapist
• Type of Report: Initial
• Report Date (Section B): 01/18/2017

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other