MAUDE Adverse Event Report: PROCTER & GAMBLE INC ALWAYSHEAVYADULTINCONTINENCEDISCREET; GARMENT, PROTECTIVE, FOR INCONTINENCE

Lot Number NOT AVAILABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Experienced a severe (allergic reaction) anaphylaxis [anaphylactic reaction], experienced a severe allergic reaction (anaphylaxis) [hypersensitivity], discreet diapers for post-partum bleeding [device use issue].Case description: a female consumer of unspecified age reported spontaneously via e-mail on (b)(6) 2017 that she recently purchased always heavy adult incontinence discreet for postpartum bleeding.She described that she experienced a severe allergic reaction (anaphylaxis) and was hospitalized.She sought a list of the chemicals in the product so she could pinpoint what exactly she had an allergic reaction to.The case outcome was unknown.Taken previously - unknown / tolerated - unknown.Treatment details: unknown.Relevant history: none reported.Concomitant product(s): none reported.No further information was provided.

• Brand Name: ALWAYSHEAVYADULTINCONTINENCEDISCREET
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): PROCTER & GAMBLE INC; 365 university ave; belleville, on K8N5E 9; CA K8N5E9
• 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: 6770094
• MDR Text Key: 81904791
• Report Number: 8022168-2017-00002
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other