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

Catalog Number 828714

Device Problem Device Emits Odor (1425)

Patient Problem Abdominal Pain (1685)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2017 sample and further information concerning the event received (b)(6) (initial contact was (b)(6) but in complete information concerning the nature of event not provided till later).

Event Description

(b)(6) 2017 customer indicated that wife complained of condom odor and abdominal pain after using the product.After inquiries for details of the pain and whether doctor intervention was required, company was advised on (b)(6) 2017 that an antibiotic was prescribed and that they had abdominal pain when using a new condom.

Manufacturer Narrative

On (b)(6) 2017 sample and further information concerning the event received (b)(6) (initial contact was (b)(6) but in complete information concerning the nature of event not provided till later).On 12/06/2017 - review of batch record indicated no non conformity in process.All release criteria were met and no further corrective action was applicable.

Event Description

On (b)(6) 2017 customer indicated that wife complained of condom odor and abdominal pain after using the product.After inquiries for details of the pain and whether doctor intervention was required, company was advised on (b)(6) 2017 that a antibiotic was prescribed and that they had abdominal pain when using a new condom.

• Brand Name: SKYN POLYISOPRENE MALE CONDOMS
• Type of Device: SKYN POLYISOPRENE MALE CONDOMS
• 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: 6997679
• MDR Text Key: 90935775
• Report Number: 1019632-2017-00014
• 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: 11/02/2017,12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 828714
• Device Lot Number: 1704P20722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2017
• Distributor Facility Aware Date: 09/20/2017
• Event Location: Home
• Date Report to Manufacturer: 11/02/2017
• 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