MAUDE Adverse Event Report: PROCTER & GAMBLE GMBH & CO., MANUFACTURING OHE ALWAYS DISCREET, MODERATE 4. LONG LENGTH; GARMENT, PROTECTIVE, FOR INCONTINENCE

Lot Number 8133478600 58

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Itching Sensation (1943)

Event Date 09/22/2018

Event Type  Injury  

Event Description

After wearing always discreet pads for 6 hours, i had to remove the pad due to severe itch.These symptoms have continued into the next day.I had previously used these pads and developed severe itch and irritation, but had not made the connection to the use of the pads.That event lasted 2 weeks until the symptoms subsided.During that time i tried using several topical creams and powders to provide relief.Dates of use: (b)(6) 2018.Reason for use: bladder incontinence.

• Brand Name: ALWAYS DISCREET, MODERATE 4. LONG LENGTH
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): PROCTER & GAMBLE GMBH & CO., MANUFACTURING OHE
• MDR Report Key: 7905773
• MDR Text Key: 121742427
• Report Number: MW5080080
• 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: Patient
• Type of Report: Initial
• Report Date: 09/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 8133478600 58
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 113