MAUDE Adverse Event Report: SURETEX PROPHYLACTICS (I), LTD SKYN; SKYN LARGE POLYISOPRENE LUBRICATED CONDOM

Lot Number 1606P10722

Device Problem Cross Reactivity (1137)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

On 12/29/2016 - a review of the device history record indicates that compounding and manufacturing process were all within specified parameters.Inspection of (b)(4) pieces of retained samples were tested for lubricant quantity and results are within specification requirements of the product.(b)(4) pieces of retained samples have been sent to outside microbiological lab for testing and another (b)(4) retain samples sent to external laboratory for protein test (protein's associated with latex allergen).This report will be updated upon completion of the those evaluations.

Event Description

(b)(6) 2016 user indicated that they were having an allergic reaction from the use of skyn large polyisoprene condom.The user wished to know the ingredients used in the production of the condom, so that she could discuss with her physician as to whether an ingredient(s) contributed to the reaction.

Manufacturer Narrative

On 12/29/2016 - a review of the device history record indicates that compounding and manufacturing process were all within specified parameters.Inspection of 13 pieces of retained samples were tested for lubricant quantity and results are within specification requirements of the product.Ten (10) pieces of retained samples have been sent to outside microbiological lab for testing and another 10 retain samples sent to external laboratory for protein test (protein's associated with latex allergen).This report will be updated upon completion of the those evaluations.On 03/03/2017 - retain evaluations for microbial testing indicated retain samples passed parameters.Aqueous extractable protein evaluation showed results within acceptable limit.No further action to be taken.

Event Description

On 12/23/2016 user indicated that they were having an allergic reaction from the use of skyn large polyisoprene condom.The user wished to know the ingredients used in the production of the condom so that she could discuss with her physician as to whether an ingredient(s) contributed to the reaction.

• Brand Name: SKYN
• Type of Device: SKYN LARGE POLYISOPRENE LUBRICATED CONDOM
• Manufacturer (Section D): SURETEX PROPHYLACTICS (I), LTD; 74-91 kiadb estate; jigani ii phase, anekal taluk; bangalore karnataka, bangalore 56210 6; IN 562106
• MDR Report Key: 6223274
• MDR Text Key: 63909888
• Report Number: 1019632-2017-00001
• Device Sequence Number: 1
• Product Code: MOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2017,03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1606P10722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2017
• Distributor Facility Aware Date: 12/13/2016
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 01/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR