MAUDE Adverse Event Report: PROCTER & GAMBLE, INC ALWAYSPADSULTRAULTRATHINADVPRTCWINGLONGUNSCNT88CT; PAD, MENSTRUAL, UNSCENTED - HHD

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 11/10/2023

Event Type  Injury  

Event Description

Rash arms and legs [rash].Case narrative: the consumer, a female of unspecified age, reported spontaneously via e-mail on (b)(6) 2023 that they used always pads ultra ultra thin advanced protection wing long unscented 88ct, beginning on an unspecified date.She experienced a rash, beginning on an unspecified date.Treatment details: unknown.It was unspecified if she used the exact same version of the device in the past.Concomitant products: none reported.Relevant history: none reported.The event and case outcomes were unknown.No further information was provided.16-nov-2023 received digital safety assessment survey: the consumer, a 37 year old, used the pads every day, beginning on (b)(6) 2023.She was still using the pads at the time of this report.She experienced a rash on her arms and legs, beginning on (b)(6) 2023.The consumer visited a doctor at an urgent care/hospital clinic visit and was there for 7 consecutive days (in (b)(6) 2023).Treatment details: rash cream.The rash on her arms and legs was improved.The case outcome was improved.No further information was provided.Amendment to contact received on (b)(6) 2023 - digital safety assessment survey: the case is assessed serious for serious illness/injury/deterioration in health as the adverse event resulted in significant injury (causing hospitalization).No further information was provided.

Manufacturer Narrative

There is insufficient information to perform an investigation.

• Brand Name: ALWAYSPADSULTRAULTRATHINADVPRTCWINGLONGUNSCNT88CT
• Type of Device: PAD, MENSTRUAL, UNSCENTED - HHD
• Manufacturer (Section D): PROCTER & GAMBLE, INC; 355 university ave; belleville K8N5E 9; CA K8N5E9
• Manufacturer (Section G): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: manager affairs,feminine care ; winton hill business center b; 6280 center hill avenue; cincinnati 45224
• MDR Report Key: 18565924
• MDR Text Key: 333508545
• Report Number: 8022168-2024-00001
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2024

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female