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

Lot Number TT8320

Device Problem Break (1069)

Patient Problems Erythema (1840); Rash (2033)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

The consumer states that her and her boyfriend were using this product and that it snapped.She then alleges that she had a red rash the next day.She specified that it was the (b)(6) condom.We are reporting this conservatively in the absence of additional information from the consumer.

• Brand Name: TROJAN PLEASURE PACK CONDOMS UNSPECIFIED
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing, nj
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC.; 1851 touchstone road; south chesterfield, va
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, nj ; 8067868
• MDR Report Key: 10428585
• MDR Text Key: 204404181
• Report Number: 2280705-2020-00025
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Lot Number: TT8320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2020
• 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