FDA Adverse Event Injury Summary report: N

TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS

MDR report key: 10189110 · Received June 24, 2020

Report

Report Number: 2280705-2020-00020
Event Type: Injury
Date Received: June 24, 2020
Date of Event: May 26, 2020
Report Date: September 25, 2020
Manufacturer: CHURCH & DWIGHT CO., INC.
Product Code: HIS
UDI-DI: 00002260002019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

PRODUCT RECEIVED AND EVALUATED. THE EVALUATION DOES NOT CHANGE INITIAL REPORTABILITY REQUIREMENTS.

Additional Manufacturer Narrative · 1

PMA/510(K)#: SINCE THIS IS A COLLECTION OF VARIOUS CONDOMS, THERE ARE A FEW 510(K) NUMBERS: K901192, K912901, K912901, K901194.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
655409	TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS	CONDOM	HIS	CHURCH & DWIGHT CO., INC.	2260002019	TT0006	00002260002019

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Other