MAUDE Adverse Event Report: SURETEX LTD SKYN; POLYISOPRENE LATEX CONDOM

Model Number NOT PROVIDED

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 12/20/2016

Event Type  Injury  

Event Description

On 01/13/2017 - customer indicated that in (b)(6), they purchased a skyn condom and after use, it caused irritation and scratching for the next 24 hours.Partner had no symptoms.After, discharge from vaginal area started.Customer indicated that they did not have purchase receipt or samples to provide.

Manufacturer Narrative

On 03/02/2017 a review of the batch record indicated no deviations or out of spec results during in process or finished good release.Protein testing was conducted for batch produced; results show passed.No further root cause could be established and no further action can be taken at this time.

Event Description

(b)(6) 2017 - customer indicated that in (b)(6), they purchased a skyn condom and after use, it caused irritation and scratching for the next 24 hours.Partner had no symptoms.After, discharge from vaginal area started.Customer indicated that they did not have purchase receipt or samples to provide.

• Brand Name: SKYN
• Type of Device: POLYISOPRENE LATEX CONDOM
• Manufacturer (Section D): SURETEX LTD; 31/1 moo 4, tambon khao hua kw; amphur phunphin suratthani, surat thani 84130 ; TH 84130
• MDR Report Key: 6250549
• MDR Text Key: 64779544
• Report Number: 1019632-2017-00003
• 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: 01/13/2017,03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: 115091
• Device Lot Number: 1412413316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2017
• Event Location: Home
• Date Report to Manufacturer: 03/02/2017
• 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: 30 YR