MAUDE Adverse Event Report: SURETEX LIMITED SKYN ELITE LARGE CONDOM 12CT WM

Model Number	7412
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Referred by the consumer product safety commission of the united states of america.On (b)(6) 2022, me, (b)(6) and my wife were having intercourse, when the condom broke.The condom broke, at the tip, while ejaculating, inside of my wife.Because the condom broke, while ejaculating, inside of my wife, there is a good chance that my wife will have an unplanned pregnancy.I consider a product that breaks, such as condom, to be a defective product, no matter whether the defect was intentional or not.This defective condom was a lifestyles skyn, synthetic polyisoprene condom.The condom's package states descriptive details such as elite large, elite grand format, lot: 2107733116, exp: 2026-06-30, nom: 56mm, mfg/fab: thailand.I would like this organization to seek any and all remedies possible for this damaged product, that i relied on, to prevent an unplanned pregnancy.

• Brand Name: SKYN ELITE LARGE CONDOM 12CT WM
• Common Device Name: SKYN ELITE LARGE
• Manufacturer (Section D): SURETEX LIMITED; 31/1 moo 4,suratthani-thakuap; tambon khao hua kwai; suratthani, amphur phunphin 84130 ; TH 84130
• Manufacturer (Section G): SURETEX LIMITED; 31/1 moo 4, suratthani-thakuap; tambon khao hua kwai; suratthani, amphur phunphin 84130 ; TH 84130
• Manufacturer Contact: niramol bunnuan ; 31/1 moo 4, suratthani-thakuap; tambon khao hua kwai; suratthani, amphur phunphin 84130 ; TH 84130
• MDR Report Key: 15797217
• Report Number: 3002808272-2022-00000
• Device Sequence Number: 4649443
• Product Code: MOL
• UDI-Device Identifier: 00070907274125
• UDI-Public: 070907274125
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171172
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 06/30/2026
• Device Model Number: 7412
• Device Catalogue Number: N/A
• Device Lot Number: 2107733116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male