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

Model Number 7312

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information.On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment.No details to the medication prescribed were given.

Event Description

On (b)(6) 2017 customer indicated that he experienced a reaction after use of the product.No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information.On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment.No details to the medication prescribed were given.

Manufacturer Narrative

No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information.On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment.No details to the medication prescribed were given.On 02/13/2018 review of device history record conducted.Customer returned samples tested for visual and lubricant quantity.No deviation or assignable cause could be determined from assessment.No further corrective action can be assigned at this time.

Event Description

On (b)(6) 2017 customer indicated that he experienced a reaction after use of the product.No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information.On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment.No details to the medication prescribed were given.

• Brand Name: SKYN
• Type of Device: POLYISOPRENE LATEX 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: 7159746
• MDR Text Key: 96225177
• Report Number: 3013388459-2018-00001
• 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: 01/03/2018,02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7312
• Device Lot Number: 1608P40122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2018
• Distributor Facility Aware Date: 11/21/2017
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 01/03/2018
• 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: 30 YR