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

Catalog Number 123625

Device Problem Device Emits Odor (1425)

Patient Problem Bacterial Infection (1735)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

On 03/01/2017 - after an indication of customer infection requiring medical treatment on (b)(6), initial report filing.Manufacturing has reviewed the device history record.No out of specification or in process deviations noted.Product was released consistent with all internal specifications.Retained samples did indicate a slight odor.In 2016 - to decrease the odor profile, modification to the in line leaching process, ex dip washing, and odor masking agent were introduced to alleviate the cosmetic odor of the condoms.

Event Description

On 03/01/2017 - customer indicated that upon opening the product, the product had a "foul smell".Several other foiled products from the same carton had the same smell.Customer indicated on (b)(6) that partner had an infection and sought medical attention for treatment of infection.

Manufacturer Narrative

On 03/01/2017 - after an indication of customer infection requiring medical treatment on (b)(6), initial report filing.Manufacturing has reviewed the device history record.No out of specification or in process deviations noted.Product was released consistent with all internal specifications.Retained samples did indicate a slight odor.In 2016 - to decrease the odor profile, modification to the in line leaching process, ex dip washing, and odor masking agent were introduced to alleviate the cosmetic odor of the condoms.On 05/02/2017: > a review of the device history record indicated that the product was manufactured and processed within specification.No deviations were noted in the production record.> > micro testing of retain samples indicated that samples were within test specifications > protein testing of retained samples were evaluated and are within acceptable limit.> returned samples from customer were inspected and slight odor was detected.> a masking agent along with process enhancements for leaching process in production to lessen this cosmetic aesthetic was cleared under a 510k has since been implemented and is to be shipped by end of june 2017.No other actions to take place.

Event Description

On 03/01/2017 - customer indicated that upon opening the product, the product had a "foul smell".Several other foiled products from the same carton had the same smell.Customer indicated on (b)(6) that partner had an infection and sought medical attention for treatment of infection.

• Brand Name: SKYN POLYISOPRENE CONDOM
• Type of Device: POLYISOPRENE 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: 6368476
• MDR Text Key: 68665969
• Report Number: 1019632-2017-00005
• 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: 03/01/2017,05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 123625
• Device Lot Number: 1606P40922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Distributor Facility Aware Date: 01/17/2017
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 03/01/2017
• 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: 20 YR