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

Catalog Number 164672

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 01/26/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 consumer indicated that they used skyn elite polyisoprene condom and believed that they developed a urinary tract infection.Visit to doctor was done and a uti was confirmed.

Manufacturer Narrative

On 04/10/2018 the device history record (dhr) of the lots were analyzed with respect to the reported complaint.The lots were produced using synthetic polyisoprene with existing compounding formulation and there is no change in dosage or change of raw materials and chemicals used.And also there is no change in chemicals used in various stage of manufacturing process.The lots were inspected at various stages of manufacturing process & released as per the documented quality plan.No deviations identified.No root cause can be assigned.Record closed.

Event Description

On (b)(6) 2018 consumer indicated that they used skyn elite polyisoprene condom and believed that they developed a urinary tract infection.Visit to doctor was done and a uti was confirmed.

• Brand Name: SKYN
• Type of Device: POLYISOPRENE MALE 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 Key: 7266332
• MDR Text Key: 99907782
• Report Number: 3013388459-2018-00003
• Device Sequence Number: 1
• Product Code: MOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2018,04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 164672
• Device Lot Number: 1610P20722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2018
• Distributor Facility Aware Date: 01/26/2018
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR