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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURETEX PROPHYLACTICS (I), LTD. SKYN ELITE; POLYISOPRENE CONDOM
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SURETEX PROPHYLACTICS (I), LTD. SKYN ELITE; POLYISOPRENE CONDOM Back to Search Results
Catalog Number 164672
Device Problems Cross Reactivity (1137); Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Irritation (1941); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146)
Event Date 05/23/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 customer indicated major irritation following use of the product.Private area became very red, swollen, and burning sensation.Customer indicated that they went to see a doctor.
 
Manufacturer Narrative
09/25/2018.A review of the batch history record indicates no deviation or out of specification results in the manufacture of the lot.A microbiological assessment of lot retain samples indicates that all product passed specification criteria.Returned samples ((b)(6) 2018) were also subject to microbiological assessment and results indicated that samples passed specification criteria.No root cause can be assigned and the complaint record is closed.
 
Event Description
On (b)(6) 2018 customer indicated major irritation following use of the product.Private area became very red, swollen, and burning sensation.Customer indicated that they went to see a doctor.
 
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Brand Name
SKYN ELITE
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 Key7573494
MDR Text Key110220637
Report Number3013388459-2018-00007
Device Sequence Number1
Product Code MOL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 06/06/2018,09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number164672
Device Lot Number1801P20722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2018
Distributor Facility Aware Date05/23/2018
Device Age5 MO
Event Location Home
Date Report to Manufacturer06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age20 YR
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