MAUDE Adverse Event Report: PROCTER & GAMBLE GMBH & CO., MANUFACTURING OHE ALWAYS ULTRA THIN UNSCENTED SIZE 1; PAD, MENSTRUAL, UNSCENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Caustic/Chemical Burns (2549)

Event Date 01/17/2022

Event Type  Injury  

Event Description

I had gotten my period and used the always ultra thin unscented size 1 pads.They caused a chemical burn which i mistaken for "diaper rash".Used them again this month after one hour of using one singular pad the entire pad was burnt into my skin.So i am left uncomfortable cant sit down sore behind and front area.My job entails me to sit at a computer desk for days and days i have suffered.

Event Description

I had gotten my period and used the always ultra thin unscented size 1 pads.They caused a chemical burn which i mistaken for "diaper rash".Used them again this month after one hour of using one singular pad the entire pad was burnt into my skin.So i am left uncomfortable cant sit down sore behind and front area.My job entails me to sit at a computer desk for days and days i have suffered.

• Brand Name: ALWAYS ULTRA THIN UNSCENTED SIZE 1
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE GMBH & CO., MANUFACTURING OHE
• MDR Report Key: 13578825
• MDR Text Key: 285988325
• Report Number: MW5107590
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2022
• Patient Sequence Number: 1
• Treatment: DESVENLAFAXINE
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White