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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCTER & GAMBLE, INC. ALWAYS PAD, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) PAD 1 APPLIC NONE

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PROCTER & GAMBLE, INC. ALWAYS PAD, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) PAD 1 APPLIC NONE Back to Search Results
Event Type  Injury  
Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas): rash from pad [rash]. Case description: a consumer reported that her daughter, age unspecified, used always pad, version/absorbency/scent unknown and reported that her daughter developed a rash that became so bad she was admitted to the hospital for approximately 1 week and treated with an unspecified cream. The case outcome was improved. No further information was provided.

 
Manufacturer Narrative

Lot number was provided by the reporter but product was not available for return therefore batch retain investigation requested and results pending.

 
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Brand NameALWAYS PAD, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) PAD 1 APPLIC
Type of DeviceNONE
Manufacturer (Section D)
PROCTER & GAMBLE, INC.
belleville, ontario
CA 
Manufacturer (Section G)
PROCTER & GAMBLE, INC.
355 university ave.
belleville, ontario K8N5 E9
CA  K8N5E9
Manufacturer Contact
mgr.
6110 center hill ave.
winton hill business ctr.
cincinnati , OH 45224
MDR Report Key2848251
Report Number8022168-2012-00001
Device Sequence Number1
Product CodeHHD
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 10/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2012
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
Was the Report Sent to FDA? No
Date Manufacturer Received10/25/2012
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/21/2012 Patient Sequence Number: 1
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