MAUDE Adverse Event Report: PROCTER & GAMBLE, INC ALWAYSMEDIUMADULTINCONTINENCEDISCREETBASEVERLONGEXTHEAVY28CT; GARMENT, PROTECTIVE, FOR INCONTINENCE - EYQ

Device Problem Insufficient Information (3190)

Patient Problems Anaphylactic Shock (1703); Dyspnea (1816); Burning Sensation (2146); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

There is insufficient information to perform an investigation.

Event Description

Anaphylactic shock [anaphylactic shock].Felt like a pillow was being shoved down my throat [respiratory disorder], eyes burning [eye irritation], inside of nose burning [nasal discomfort], feeling ill [illness], rancid scent - always [product odour abnormal].Case narrative: the consumer, a female of unspecified age, reported spontaneously via rating/review on (b)(6)2023 that she used always medium adult incontinence discreet base version long extra heavy 28ct, beginning on an unspecified date.The consumer reported that the product had a rancid scent.She felt instantly ill as soon as she opened the bag.Her symptoms included burning eyes and burning inside her nose.She then felt like, "a pillow was being shoved down her throat," and experienced anaphylactic shock.Treatment details: unknown.Relevant history: none reported.Concomitant product(s): none reported.It was unknown if the consumer previously used this exact same product.The event and case outcomes were unknown.No further information was provided.

• Brand Name: ALWAYSMEDIUMADULTINCONTINENCEDISCREETBASEVERLONGEXTHEAVY28CT
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE - EYQ
• Manufacturer (Section D): PROCTER & GAMBLE, INC; 355 university ave; belleville K8N5E 9; CA K8N5E9
• Manufacturer (Section G): PROCTER & GAMBLE, INC; 355 university ave; belleville K8N5E 9; CA K8N5E9
• Manufacturer Contact: manager affairs,feminine care ; winton hill business center b; 6280 center hill avenue; cincinnati 45224
• MDR Report Key: 16940160
• MDR Text Key: 315312765
• Report Number: 8022168-2023-00002
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female