MAUDE Adverse Event Report: PROCTOR AND GAMBLE ALWAYS SANITARY PADS; GARMENT, PROTECTIVE FOR INCONTINENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fungus (1872); Headache (1880); Itching Sensation (1943); Burning Sensation (2146)

Event Date 05/02/2017

Event Type  Injury  

Event Description

Changed from using poise pads and started using always pads and that's when the burning and itching started in the vaginal area.Used poise and equate pads but biopsy (b)(6) 2018 - showed melanophagic dermatitis (contact) the condition still prevailed - even for the last several months when no pads were used at all.On one web site i went to it said a chemical called "methacrylate" was found on both sides of the pads and this substance can be an irritant."metlance" plate in pads.Started in (b)(6) 2017 when i started wearing "always" and "poise" sanitary pads.Went to (b)(6) urgent care in (b)(6) to check for a uti infection.Nurse practitioner said no uti but a yeast infection and prescribed monistat 7.Used for 7 days with no results.Went to dr.(b)(6) and he said it was not a yeast infection but a culture showed a uti.He said to see dr.(b)(6) (after he prescribed hydrocortisone 1 percent).He said looked like 2 different problems - fungus on the butt and contact dermatitis in the vaginal area - a latex allergy.Butt area itched, vaginal area burned.Scraping test showed fungus on butt and after 2.5 percent hydrocortisone for 5 weeks was put on lamisil for butt fungus and for vaginal area.After using that for about a week noticed on the tube that lamisil should not be used in vaginal area.Stopped that and went to dr.Hammer, my primary care doctor.She said it was yeast infection, subacute vaginitis and prescribed clotrimazole 1 percent 7 day anti-fungal vaginal crea.Used this for 5 days with no improvement.Was then put on fluconazole 100 mg pill for 7 days.After the 4th day experienced "flashing lights" associated wit migraines.On the 5th day got the "flashing lights" again followed by the migraine headache.There was no improvement and the nurse said to discontinue use and see dermatologist again.Only using "wesctin" now, and still have the problem.Dr.(b)(6) said to use lamisil for 4 weeks, which i did but with no results.Have been using nothing for several weeks.Dr.(b)(6) swab cultures were (b)(6) for fungus and bacteria.Melanophagic dermatitis in diagnosis.Next to dr.(b)(6) for second opinion and she recommended dr.(b)(6) who specializes in this kind of a dermatological problem.Dr.(b)(6) also prescribed another steroid cream that was made patent but i have opted to see the new doctor to see what her treatment is.See her on (b)(6) 2018.Burning in vaginal and rectal areas - itching on the butt area.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.

• Brand Name: ALWAYS SANITARY PADS
• Type of Device: GARMENT, PROTECTIVE FOR INCONTINENCE
• Manufacturer (Section D): PROCTOR AND GAMBLE
• MDR Report Key: 7380872
• MDR Text Key: 104024208
• Report Number: MW5076203
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 82