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U.S. Department of Health and Human Services

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

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CONDOM RESOURCE RUFF RIDER: RIBBED CONDOM Back to Search Results
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).
 
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Brand NameRUFF RIDER: RIBBED CONDOM
Type of DeviceRUFF RIDER: RIBBED CONDOM
Manufacturer (Section D)
CONDOM RESOURCE
MDR Report Key6245323
MDR Text Key64759160
Report NumberMW5067190
Device Sequence Number1
Product Code HIS
Reporter Country CodeUS
Number of Events Reported1
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 Received01/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/09/2017 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.
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