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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURETEX LTD SKYN; MALE POLYISOPRENE CONDOM - LUBRICATED
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SURETEX LTD SKYN; MALE POLYISOPRENE CONDOM - LUBRICATED Back to Search Results
Lot Number 1611563116
Device Problem Cross Reactivity (1137)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 07/14/2017
Event Type  Injury  
Event Description
Customer indicated they experienced a reaction after using the device.She contacted her physician who prescribed a medication for irritation and dermatitis.
 
Manufacturer Narrative
07/21/2017: a review of history batch record indicates no deviations or negative observations.Protein testing was conducted on the batch produced that showed results within specification.No root cause can be identified and no further corrective action applies as of this date.
 
Event Description
Customer indicated they experienced a reaction after using the device.She contacted her physician who prescribed a medication for irritation and dermatitis.
 
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Brand Name
SKYN
Type of Device
MALE POLYISOPRENE CONDOM - LUBRICATED
Manufacturer (Section D)
SURETEX LTD
31/1 moo 4, tambon khao hua kw
amphur phunphin suratthani, 84130
TH  84130
MDR Report Key6720858
MDR Text Key80269224
Report Number1019632-2017-00009
Device Sequence Number1
Product Code MOL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot Number1611563116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2017
Distributor Facility Aware Date07/14/2017
Device Age1 YR
Event Location Home
Date Report to Manufacturer07/18/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age20 YR
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