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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURETEX PROPHYLACTICS (I), LTD. SKYN SYNTHETIC POLYISOPRENE CONDOM
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SURETEX PROPHYLACTICS (I), LTD. SKYN SYNTHETIC POLYISOPRENE CONDOM Back to Search Results
Catalog Number 114668
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Urticaria (2278)
Event Date 04/04/2018
Event Type  Injury  
Manufacturer Narrative
On (b)(4) 2018 device history record evaluation conducted.Batch record indicates no deviations from established acceptance criteria.Retain samples subject to microbiological testing, results indicate total yeast and mold below cfu requirement and absence of bacteria.No other deviations noted in batch record and no root cause can be established.No further action to be taken.
 
Event Description
On (b)(6) 2018 (b)(6) customer indicates that after use of the product, the penis developed hives.Medical advice was sought and the consumer was advised to cease use of the product.No medication was prescribed.
 
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Brand Name
SKYN SYNTHETIC POLYISOPRENE CONDOM
Type of Device
POLYISOPRENE CONDOM
Manufacturer (Section D)
SURETEX PROPHYLACTICS (I), LTD.
74-91 kiadb industrial estate
jigani ii phase,anekal taluk
bangalore karnataka, in-ka 560 1 05
IN  560 105
MDR Report Key7507729
MDR Text Key108050766
Report Number3013388459-2018-00006
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
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number114668
Device Lot Number1711971822
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2018
Distributor Facility Aware Date04/10/2018
Device Age1 YR
Event Location Home
Date Report to Manufacturer04/27/2018
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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