MAUDE Adverse Event Report: PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE ALWAYSPADS; PAD, MENSTRUAL, UNSCENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Peeling (1999); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Return of product has been requested.Product and lot number was not provided by reporter therefore unable to proceed with product investigation at this time.Full evaluation will occur upon receipt of returned product.This (b)(6) always pad adverse event case likely involves a product manufactured at any one of four procter & gamble plants located in: (b)(4).Since the always pad product involved in this case is similar to that sold in the us, and since only one of these sites has an active medical device establishment number, we will be submitting this case under (b)(4).

Event Description

Skin peeling off vagina [vaginal exfoliation] rash-vagina [vulvovaginal rash] case description: a mother reported that her (b)(6) year old adult daughter used always pads, unknown version, use and frequency, and her daughter developed a rash in her vaginal area so badly that her skin was peeling off and she has been admitted to the hospital.Treatment details were unknown.The case outcome was not recovered/not resolved.Relevant medical history: none reported.Concomitant product(s): none reported.No further information was provided.

• Brand Name: ALWAYSPADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE; p&g strasse 1; d-74564; crailsheim, D-718 0; GM D-7180
• Manufacturer (Section G): PROCTER & GAMBLE INC; 365 university ave; belleville, on K8N5E 9; CA K8N5E9
• Manufacturer Contact: regulatory feminine care ; 6110 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 5527261
• MDR Text Key: 41224961
• Report Number: 9680085-2016-00001
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 29 YR