MAUDE Adverse Event Report: SURETEX, LTD. LIFESTYLES HEALTHCARE SKYN ELITE LARGE CONDOMS; CONDOM, SYNTHETIC

Model Number NOM: 56MM

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

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

Event Date 06/08/2022

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.Fda safety report id # (b)(4).

• Brand Name: LIFESTYLES HEALTHCARE SKYN ELITE LARGE CONDOMS
• Type of Device: CONDOM, SYNTHETIC
• Manufacturer (Section D): SURETEX, LTD.
• MDR Report Key: 14732147
• MDR Text Key: 294936470
• Report Number: MW5110373
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: NOM: 56MM
• Device Lot Number: 2107733116
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CREATININE; LEVOTHYROXINE; MULTIVITAMIN ; PROTEIN
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White