SKYN 7324

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for SKYN 7324 manufactured by Suretex Prophylactics (i), Ltd..

Event Text Entries

[123821419] On (b)(6) 2018 customer purchased a new large box of the skyn condoms. Odor from condoms was classified as "terrible" by the consumer. User indicates that they acquire a vaginal bacterial infection and went to the emergency room due to the pain. The user indicates that the condom "feels" different from previous purchases of the product. After using them, user indicates a very severe burning sensation in vagina and urethra area.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3013388459-2018-00009
• MDR Report Key: 7969105
• Date Received: 2018-10-16
• Date of Report: 2018-11-27
• Date of Event: 2018-10-14
• Date Facility Aware: 2018-10-14
• Report Date: 2018-10-16
• Date Reported to FDA: 2018-10-16
• Date Reported to Mfgr: 2018-10-16
• Date Added to Maude: 2018-10-16
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SKYN
• Generic Name: POLYISOPRENE CONDOM
• Product Code: MOL
• Date Received: 2018-10-16
• Model Number: 7324
• Lot Number: 1803P10822
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 5 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SURETEX PROPHYLACTICS (I), LTD.
• Manufacturer Address: 74-91 KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK BANGALORE KARNATAKA, IN-KA 560 105 IN 560 105

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-10-16