MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE; DRESSING, WOUND, OCCLUSIVE

Model Number 381371172979

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

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id, age, gender, weight, ethnicity and race: patient identifier, age at time of event, gender, weight, and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand hydroseal bandages all purpose 10ct usa (b)(4) 8137117297usa 8137117297usa, lot number ni.Udi #: (b)(4), upc #: 381371172979, lot # ni, exp date: na.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Sepsis is a life-threatening organ dysfunction caused by dysregulated host response to infection (jama 2016).It is a systemic response to an infection and is not likely to develop from a minor wound, for which this product is intended to be used, unless there are risk factors for development of sepsis such as the type of wound (e.G., bites or burns) or an immunocompromised state.In this case, although the reporter allegedly developed ¿sepsis¿ based on verbatim, and attributed it to the use of this product, the event is unlikely to develop without any risk factors, and the insufficient information in the case (e.G., manner of use, time from use to onset of sepsis, risk factors such as medical history/immunocompromised state, and diagnosis/management at the hospital) precludes further meaningful medical assessment.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported on social media an event with band aid brand hydroseal bandages all purpose.Consumer stated that product was used to treat a wound.As time went on during use, the wound became much worse.It was stated that the consumer ended up in the hospital with sepsis.

• Brand Name: BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST A/S; holtedam 1; hovedsaden DK-30 50; DA DK-3050
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 13949422
• MDR Text Key: 288185247
• Report Number: 2214133-2022-00016
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381371172979
• UDI-Public: (01)381371172979
• Combination Product (y/n): N
• 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: 03/03/2022

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
• Device Model Number: 381371172979
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization