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U.S. Department of Health and Human Services

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

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RECKITT BENCKISER DUREX FOREIGN BRAND CONDOM - UNSPECIFIED Back to Search Results
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.
 
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Brand NameDUREX FOREIGN BRAND CONDOM - UNSPECIFIED
Type of DeviceCONDOM
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 Key6291534
MDR Text Key66223358
Report Number3003071219-2017-00001
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
PMA/PMN Number
K980319
Number of Events Reported1
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 Received01/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
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 Treatment Data
Date Received: 01/31/2017 Patient Sequence Number: 1
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