RUFF RIDER: RIBBED CONDOM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for RUFF RIDER: RIBBED CONDOM manufactured by Condom Resource.

Event Text Entries

[64759160] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5067190
• MDR Report Key: 6245323
• Date Received: 2017-01-09
• Date of Report: 2016-08-11
• Date of Event: 2003-06-01
• Date Added to Maude: 2017-01-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: RUFF RIDER: RIBBED CONDOM
• Generic Name: RUFF RIDER: RIBBED CONDOM
• Product Code: HIS
• Date Received: 2017-01-09
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONDOM RESOURCE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit	2017-01-09