MAUDE Adverse Event Report: RECKITT BENCKISER DUREX FOREIGN BRAND CONDOM - UNSPECIFIED

Device Problem Material Rupture (1546)

Patient Problems Exposure to Body Fluids (1745); Viral Infection (2248)

Event Type  Injury  

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 not specify the variety of durex that was used.The patient also did not provide the batch details for the product nor returned any of the remaining unopened product for quality analysis.Therefore, the company is unable to conduct any further investigation at this moment in time.Further information is expected.The product labelling also states that "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 Description

Initial report, received date: 16-jan-2017, received from consumer relations, country: (b)(6), (b)(4).Suspect product: durex general unspecified condoms.Expiry date: mar-2019.Case reference number (b)(4) is a report sent by a consumer which refers to a male consumer age unknown.It was reported that in 2016; a male consumer age unknown used durex general unspecified condoms, frequency, route, indication, stop date and duration were all unknown.Consumer stated that he was using the condoms for a while at the time of reporting with expiry date mar-2019.Consumer stated that last year 1 condom broke and now he has (b)(6).Consumer stated that during last weekend some other condoms broke again.Consumer stated that he had condoms from 2010 and they were good.The case was deemed serious because it was classed as medically significant due to (b)(6) infection.No further information was available at the time of report.Case assessment of durex general unspecified condoms is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unknown.Case outcome: unknown.

• Brand Name: DUREX FOREIGN BRAND CONDOM - UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER; 399 interpace parkway; parsippany NJ 07054 0225
• Manufacturer Contact: joanne martinez ; 399 interpace parkway; parsippany, NJ 07054-0225 ; 9734042478
• MDR Report Key: 6291534
• MDR Text Key: 66223358
• Report Number: 3003071219-2017-00001
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• PMA/PMN Number: K980319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other