MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND-AID UNSPECIFIED USA BABGENUS; TAPE AND BANDAGE, ADHESIVE

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient birth year was reported as 1958.This report is for unknown band aid bandage.Upc#, lot# and udi # is not available 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.See medwatches 8041154-2021-00026, 8041154-2021-00027, 8041154-2021-00028.The same patient is represented in each medwatches.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that wife¿s husband experienced anaphylaxis from past use of band-aid unspecified usa babgenus.The consumer went to the emergency room.There are no details regarding treatment of event.No additional information has been provided.See medwatches 8041154-2021-00026, 8041154-2021-00027, 8041154-2021-00028.The same patient is represented in each medwatches.

• Brand Name: BAND-AID UNSPECIFIED USA BABGENUS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 12380101
• MDR Text Key: 268566250
• Report Number: 8041154-2021-00029
• Device Sequence Number: 1
• Product Code: KGX
• 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: 08/18/2021

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
• Event Location: Other
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening