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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED DUREX PERFORMA CONDOM

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RECKITT BENCKISER HEALTHCARE INT. LIMITED DUREX PERFORMA CONDOM Back to Search Results
Device Problem Device Issue (2379)
Patient Problems Hypoxia (1918); Skin Discoloration (2074); No Code Available (3191)
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 specify the variety of durex that was used as durex performa condoms. The patient also neither provided 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 "if you or your partner experiences breathing difficulties, or gets blue lips when using these condoms, stop using them immediately and call a doctor. Please read the leaflet inside this pack carefully, especially if you are using condoms for non-vaginal sex. Use a condom only once. The company's assessment is serious with a relatedness of possible.
 
Event Description
Patient lips were blue [cyanosis]. Patient did not have any feeling in mouth [hypoaesthesia oral] bitter taste [dysgeusia]. Case description: received from consumer relations, country (b)(6), reference no: (b)(4). Suspect product: durex performa condoms. Case reference number de-(b)(6) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported that on an unknown date a female patient of an unknown age used durex performa condoms, frequency, route, indication, stop date and duration were all unknown. Patient stated that her boyfriend used the durex performa condoms from the durex fun explosion pack and during intercourse everything was fine. However, when we spontaneously switched to oral sex again, the bitter taste made me startled. Patient's lips were blue and she did not have any feeling in her mouth. The case was deemed serious because it was classed as medically significant due to cyanosis. No further information was available at the time of report. Case assessment of durex performa 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 unlisted. Case outcome: unknown.
 
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Brand NameDUREX PERFORMA
Type of DeviceCONDOM
Manufacturer (Section D)
RECKITT BENCKISER HEALTHCARE INT. LIMITED
dansom lane
hull, hull HU8 7 DS
UK HU8 7DS
Manufacturer (Section G)
RECKITT BENCKISER HEALTHCARE INT. LIMITED
dansom lane
hull, hull HU8 7 DS
UK HU8 7DS
Manufacturer Contact
joanne martinez
dansom lane
hull, hull HU8 7-DS
UK   HU8 7DS
MDR Report Key7054829
MDR Text Key92833030
Report Number3003071219-2017-00007
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
PMA/PMN Number
K020659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2017
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: 11/22/2017 Patient Sequence Number: 1
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