MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS

Model Number 2260002019

Device Problem Break (1069)

Patient Problem Venereal Disease (2071)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: since this is a collection of various condoms, there are a few 510(k) numbers: k901192, k912901, k912901, k901194.

Event Description

The consumer stated that four condoms broke during intercourse when used on (b)(6) 2020.He said that he went to get tested and was diagnosed with (b)(6).He further stated that the health department called him to tell him he now has (b)(6).He went to a doctor and is receiving penicillin to ease the symptoms.The consumer stated that the symptoms are ongoing.

Event Description

Product received and evaluated.The evaluation does not change initial reportability requirements.

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 actually occurred.Section g5: since this is a collection of various condoms, there are a few 510(k) numbers: k901192, k912901, k912901, k901194.

• Brand Name: TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• MDR Report Key: 10189110
• MDR Text Key: 196242506
• Report Number: 2280705-2020-00020
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00002260002019
• UDI-Public: 0002260002019
• 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,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2260002019
• Device Lot Number: TT0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR