MAUDE Adverse Event Report: CONDOM RESOURCE RUFF RIDER: RIBBED CONDOM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Undesired Nerve Stimulation (1980); Scarring (2061); Reaction (2414)

Event Date 06/01/2003

Event Type  Injury  

Event Description

I worked after having surgery and after the third year of working i had trouble physically with home cleaning finishing.I went to (b)(6) and only received low-income expected average.Over ten years and seem locked (b)(6) from income.Strength: rubber/spermicide.Quantity: few.Frequency: 1-12.How was it taken or used: on the skin.Date the person first started taking or using the product: 1990.Date the person stopped taking or using the product: 1998.Why was the person using the product: because sex partner asked me.(b)(6).Expiration date: reasons of extended visit unappreciated and not explain because i only say no to symptom prone medicine.For implanted medical devices only: "(b)(6)?, at age (b)(6)".Date the implant was put in: none.Date the implant was taken out: none.Had signs of past physical surgery and was only offered a low-income and i'm over 18 years of age.It's been 10 years and (b)(6).Won't upgrade income from low-income, to average.Used condom and have scars on my penis and a testicle sensation nerve problem.I have bump on the back of my head because i well groomed, and always high, after using catheter, (b)(6) - insect repellent.I had bumps on the tip of my penis.Sorry to rubber condoms.(b)(6).

• Brand Name: RUFF RIDER: RIBBED CONDOM
• Type of Device: RUFF RIDER: RIBBED CONDOM
• Manufacturer (Section D): CONDOM RESOURCE
• MDR Report Key: 6245323
• MDR Text Key: 64759160
• Report Number: MW5067190
• Device Sequence Number: 1
• Product Code: HIS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: #(B)(4); (B)(6); ALLERGY PILLS; HEAD SHOCK TREATMENT BUMP MEDICINE.; ITCH CREAM.; ITCH OIL; KETOCONAZOLE SHAMPOO 2 PERCENT; LOT # 097310, EXP: 04/2018; OTC MEDS: CENTRUM: HEART. ; RX MEDS: OVER THE COUNTER HEADACHE MEDICINE FOR; SMOKING.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 95