MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND FIRST AID PAPER TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number 381371161539

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

Patient Problems Burn(s) (1757); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2023

Event Type  Injury  

Event Description

A female consumer reported an event with j&j band aid brand first aid paper tape from j&j first aid all purpose first aid kit.On (b)(6) 2023, the consumer experienced burns on her skin after the product was applied to the skin.The product was used to cover up an opening from unknown surgery.The consumer sought medical attention from a health care professional (hcp).The hcp prescribed a hydrocyclin cream for burn treatment.The consumer is still experiencing the reaction.This is 1 of 2 med-watches being submitted for j&j band aid brand first aid paper tape (b)(6) 1ct usa 381371161539 with possible lot 1322h (2214133-2023-00025).See medwatch 2214133-2023-00026 which captures event for j&j band aid brand first aid paper tape (b)(6) 1ct.Usa 381371161539 with possible lot 2272h.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.A4, a5: weight, ethnicity and race were not available for reporting.D1, d2, d3, d4: this report is for one j&j band aid brand first aid paper tape 1x10yds 1ct usa 381371161539; 8137116153usa; 8137116153usa, lot number 1322h.D4: udi #: (b)(4).Upc #: 381371161539.Expiration date: na.Lot #: 1322h.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.H6: health effect clinical codes: e2402 refers to consumer & "intentional misuse/off-label use" of the product.Upon the review of johnson & johnson all purpose first aid kit 160 items usa 381372020453 product lot number 3192rm and consumer photographs, the device alleged with this event is j& j band aid brand first aid paper tape 1x10yds 1ct usa 381371161539 with two possible lot numbers (1322h and 2272h).This is 1 of 2 med-watches being submitted for j& j band aid brand first aid paper tape 1x10yds 1ct usa 381371161539 with possible lot 1322h (2214133-2023-00025).See medwatch 2214133-2023-00026 which captures event for j& j band aid brand first aid paper tape 1x10yds 1ct usa 381371161539 with possible lot 2272h.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on may 12, 2022 if information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.

• Brand Name: J&J BAND AID BRAND FIRST AID PAPER TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): DUKAL HUAZHOU QIDONG ¿ CHINA; no.2858huazhou rdairport town; pudong new district; shanghai ; CH
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 17410992
• MDR Text Key: 319932245
• Report Number: 2214133-2023-00025
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371161539
• UDI-Public: (01)381371161539(10)1322H
• 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,Followup
• Report Date: 08/21/2023

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: 381371161539
• Device Lot Number: 1322H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female