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

Model Number 7412

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 307676687
• Report Number: 3002808272-2022-00000
• Device Sequence Number: 1
• Product Code: MOL
• UDI-Device Identifier: 00070907274125
• UDI-Public: 070907274125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171172
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

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