MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TOUGH STRIPS WATERPROOF; TAPE AND BANDAGE, ADHESIVE

Model Number 9300607179460

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Tears (2516); Blister (4537); Skin Infection (4544)

Event Date 11/13/2023

Event Type  Injury  

Event Description

A parent reported an event with band-aid waterproof extra large tough strips for 7-year-old male child.Consumer reported son had a scrape on his knee from fall at school and school had applied a band-aid which was not waterproof, so consumer bought waterproof band-aid and applied on (b)(6) 2023 to son¿s knee.After consumer put waterproof band-aid, son complained itchiness around the edge of the band-aid.Consumer removed the band-aid and it had lots of small red blisters around the perimeter of the band-aid and the scrape was open and oozing with yellow liquid.Consumer sought medical attention for son to remove bandage and dressing as it was painful and traumatic for the child and was prescribed some unknown ointment and unknown antibiotics for 5 days as it became infected.Doctor thought consumer¿s son had an allergic reaction to the band-aid.It was reported that, the symptoms improved after the patient stopped using the product and the patient is not experiencing any symptoms.There is no additional information with regards to outcome for this consumer.

Manufacturer Narrative

Johnson & amp; 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 & amp; 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 & amp; johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & amp; johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.D1, d2, d3, d4: this report is for one (band aid brand tough strips waterproof extra large 10ct ap 9300607179460 9300607179460apa 9300607179460apa, lot/ctrl#: 230408).Device is not distributed in the united states, but is similar to device marketed in the usa (bab tough strips waterproof ex lg 10s usa 381370055662 8137005566usa 8137005566usa) d4: udi#: (b)(4), upc #: 9300607179460, lot#: 230408, expiration date: mar-30-2026.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 code: e0402 also refers for consumer alleged & quot; itchy and red skin ¿ allergic reaction & quot;.E1703 also refers for consumer alleged & quot; lots of small blisters & quot; e1721 also refers for consumer alleged ¿skin had opened up (subsume pain) & quot;.E1719 also refers for consumer alleged & quot; graze has become infected and scrape is oozing with yellow liquid & quot.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Johnson and 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 and 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 and johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson and johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H2, 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 april 8, 2023.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: BAND AID BRAND TOUGH STRIPS WATERPROOF
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): SHANGHAI, CHINA; 120 nan ya road; minghang, shanghai ; CH
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18311322
• MDR Text Key: 330287967
• Report Number: 1000599868-2023-00014
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 9300607179460
• UDI-Public: (01)9300607179460(17)260330(10)230408
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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: 9300607179460
• Device Lot Number: 230408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male