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

Lot Number 1511P20922

Device Problem Cross Reactivity (1137)

Patient Problem Bacterial Infection (1735)

Event Date 04/10/2017

Event Type  Injury  

Event Description

On (b)(6) 2017: user contacted customer service that since using skyn polyisoprene condoms, she has had three urinary tract infections from (b)(6) 2017.Customer indicated that they sought medical attention and was prescribed an antibiotic each time.

Manufacturer Narrative

On 06/05/5017 - investigation record: device history record for the product reviewed.All manufacturing, in process and final testing indicates no deviations from specification.Retain samples sent to external lab for evaluation.Microbiological results indicate all criteria passed.Aqueous extractable protein evaluation indicate results within specified limits.Customer returned samples evaluated by external lab for micro and the results were within specification.No assignable cause identified.No corrective action applicable.Investigation closed.

Event Description

On 04/10/2017: user contacted customer service that since using skyn polyisoprene condoms, she has had three urinary tract infections from (b)(6) 2017.Customer indicated that they sought medical attention and was prescribed an antibiotic each time.

• Brand Name: SKYN
• Type of Device: MALE LUBRICATED POLYISOPRENE CONDOM
• Manufacturer (Section D): SURETEX PROPHYLACTICS (I), LTD; 74-91 kiadb estate; jigani ii phase, anekal taluk; bangalore karnataka, 56210 6; IN 562106
• MDR Report Key: 6489802
• MDR Text Key: 72728526
• Report Number: 1019632-2017-00007
• 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: 04/13/2017,06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1511P20922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2017
• Distributor Facility Aware Date: 04/11/2017
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 04/13/2017
• 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