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

Lot Number TT2180Y

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urinary Tract Infection (2120); Caustic/Chemical Burns (2549)

Event Date 01/16/2023

Event Type  Injury  

Event Description

This spontaneous report (2023-cdw-00786, 007761202a, 007766834a) from the united states of america was reported by a 30-year-old female consumer who developed an adverse reaction and a urinary tract infection (uti) after using trojan latex magnum lubricated condoms and trojan her pleasure condoms.On an unspecified date, the consumer used trojan latex her pleasure lubricated condoms (lot numbers: tjct97452-05-sk; 72015751 and tjbf-dp-purple-01) (total used: 10).On (b)(6) 2023, the consumer used trojan magnum condoms unspecified (lot number: unknown).Immediately, she had an adverse reaction and experienced a terrible burning sensation like a urinary tract infection, which subsided after 15 minutes.She contacted the physician, who confirmed uti.She was prescribed macrobid (nitrofurantoin).However, her infection got worse, and she started experiencing burning sensations in the abdominal region.On (b)(6) 2023, she was admitted to the hospital and was receiving several medications (unspecified).According to the doctor, she might have an adverse reaction to the products.Her further testing would be conducted to determine the final diagnosis.She stated that she had never experienced any manifestations before with trojan condoms.On (b)(6) 2023, at the time of this report, she was still in the hospital.No additional information was available.The action taken with trojan latex magnum lubricated condoms and trojan her pleasure condoms was not applicable.The outcome of the events was not recovered.

Event Description

This spontaneous report (2023-cdw-00786, (b)(6)) from the united states of america was reported by a 30-year-old female consumer who developed an adverse reaction and a urinary tract infection (uti) after using trojan latex magnum lubricated condoms and trojan her pleasure condoms.On an unspecified date, the consumer used trojan latex her pleasure lubricated condoms (lot numbers: tjct97452-05-sk; (b)(6) and tjbf-dp-purple-01) (total used: 10).On (b)(6) 2023, the consumer used trojan magnum condoms unspecified (lot number: unknown).Immediately, she had an adverse reaction and experienced a terrible burning sensation like a urinary tract infection, which subsided after 15 minutes.She contacted the physician, who confirmed uti.She was prescribed macrobid (nitrofurantoin).However, her infection got worse, and she started experiencing burning sensations in the abdominal region.On (b)(6) 2023, she was admitted to the hospital and was receiving several medications (unspecified).According to the doctor, she might have an adverse reaction to the products.Her further testing would be conducted to determine the final diagnosis.She stated that she had never experienced any manifestations before with trojan condoms.On (b)(6) 2023, at the time of this report, she was still in the hospital.No additional information was available.The action taken with trojan latex magnum lubricated condoms and trojan her pleasure condoms was not applicable.The outcome of the events was not recovered.Correction for the information received on 25-apr-2023: upon review the reference number (b)(4) was found to be duplicated of (b)(4).Hence, referenced number (b)(4) was removed and the narrative was updated.

Event Description

This spontaneous report ((b)(4)) from the united states of america was reported by a consumer on 25- apr-2023 and follow up report was received via fda on 03-may-2023 and an attorney on 08-jun-2023.The consumer was 30- year-old female who developed a urinary tract infection (uti) and experienced chemical burn on her genital area and abdomen after using trojan her pleasure condoms.On an unspecified date, the consumer used trojan her pleasure condoms (lot number: tt2180y) (total used: 10).On (b)(6) 2023, she experienced a terrible burning sensation like a urinary tract infection, which subsided after 15 minutes.She contacted the physician, who confirmed she developed uti.She was prescribed macrobid (nitrofurantoin).However, her infection got worse, and she started experiencing burning sensations in the abdominal region.She visited the hospital for emergency treatment.She had a chemical burn on her genital area and abdomen, which resulted in an injury on the genital areas, and gallbladder.She received several medications (unspecified) for her symptoms.According to the doctor, she might have had an adverse reaction to the product.At the time of this report, she continued to receive treatment.No additional information was available.The action taken with trojan her pleasure condoms was not applicable.The outcome of the events was not recovered.This case was linked to (b)(4) (same reporter).Correction for the information received on 25-apr-2023: upon review the reference number (b)(4) was found to be duplicate of (b)(4).Hence, referenced number (b)(4) was removed and the narrative was updated.Fu1 (08-jun-2023) received via an attorney: new reporter added, product trojan magnum condoms unspecified updated as concomitant, lot number and expiration date of trojan her pleasure condoms updated, event adverse reaction updated to chemical burn on her genital area and abdomen.Fu2 (22-jun-2023): new information present in attorney letter received on 16-jun-2023 changed initial information; date was changed to 16-jan-2023, injury was modified to uti that spread to abdominal region, and treatment received took place at the emergency room (no hospitalization mentioned).

• Brand Name: TROJAN HER PLEASURE CONDOMS
• Type of Device: CONDOM
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: jon evison ; 469 north harrison street; princeton, NJ 08543
• MDR Report Key: 16910406
• MDR Text Key: 314983492
• Report Number: 2280705-2023-00786
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 2260097352
• UDI-Public: 2260097352
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: TT2180Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female