MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN PLEASURE PACK CONDOMS 44 CT

Model Number 2260000007

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Dizziness (2194); Foreign Body In Patient (2687)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

The consumer alleges that her and her partner had intercourse around the middle of (b)(6) 2021 and the condom (the specific condom was a trojan ultra thin from a variety pack) fell off and was inside of her.A few hours later, she experienced abdominal pain and lightheadedness.Due to this, she went to the emergency room and the emergency room doctor removed the condom.She is no longer experiencing the symptoms.This is being reported conservatively.

Manufacturer Narrative

This report and the information submitted under this report do not constitute an admission that the device or church & dwight co., inc.Or any of its employees caused or contributed to the event described herein or that the event as reported to church & dwight co., inc.Actually occurred.Updated/supplemental report with section g-6 completed.

Event Description

The consumer alleges that her and her partner had intercourse around the (b)(6) 2021 and the condom (the specific condom was a trojan ultra thin from a variety pack) fell off and was inside of her.A few hours later, she experienced abdominal pain and lightheadedness.Due to this, she went to the emergency room and the emergency room doctor removed the condom.She is no longer experiencing the symptoms.This is being reported conservatively.

• Brand Name: TROJAN PLEASURE PACK CONDOMS 44 CT
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 1851 touchstone drive; south chesterfield VA 23834
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 12121589
• MDR Text Key: 262510274
• Report Number: 2280705-2021-00031
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2260000007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female