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

Model Number 62600238207

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

Patient Problems Scarring (2061); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ethnicity: patient information was not provided for reporting.(b)(4).Lot number = (10)0458c.Device available for evaluation: device is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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.(b)(4).This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2019-00089.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.

Event Description

This event was reported by the consumer¿s mother and involves a (b)(6)-year-old male (using band-aid brand hydroseal bandages extra large.The consumer used 2 band-aid brand hydroseal bandages extra large bandages over the period of 3 days.The consumer¿s weight was (b)(6) and height was 5 feet 9 inches.The consumer did not have any allergies or relevant medical history and was not taking any medications.He did apply an unspecified bandage on (b)(6) 2019, one day prior using band-aid brand hydroseal bandages extra large.On (b)(6) 2019, the consumer used one band-aid brand hydroseal bandages extra large product to cover a small (1 cm in diameter) abrasion on his elbow.It was an open wound.After wearing the bandage for 1 day, on (b)(6) 2019, while the consumer was bathing, the area of the bandage was burning when it came in contact with water.The consumer carefully removed the bandage and noticed that the size of the wound increased and a small blister formed near the wound, where the bandage had been.The second band-aid brand hydroseal bandages extra large product was applied to keep the wound protected so it could heal.Later that day (within 24 hours of applying the second bandage), there was a white bubble forming under the bandage over the wound.Per instruction for use, this was supposed to happen and meant the product was working.On (b)(6) 2019 (2 days after the first bandage was applied), the white bubbled area had grown to about 1.5 inches in diameter and was quite swollen.The consumer¿s mother said it did not look right and she helped her son to carefully remove the second bandage.When it was removed, it revealed that the wound was now much larger and oozing with healing liquid.Some of the area around the wound, where the bandage was adhered, showed blisters.It was open and painful.The consumer¿s mother carefully covered the wound with a band-aid brand flexible fabric extra-large bandage and unspecified gauze.The use of band-aid brand hydroseal bandages extra large was discontinued.On (b)(6) 2019 (3 days after removal of the second band-aid brand hydroseal bandages extra large), the dressing was removed to let the wound air out.It was reported that the wound had become much worse.Within few hours, blisters were readily forming and popping, even as the consumer sat in the emergency room.The reporter stated that it appeared to be a severe reaction, possible allergic contact dermatitis, to whatever was in band-aid brand hydroseal bandages extra large.It did not look infected but the doctor in the emergency room took a swab from one of the blisters to test for infection.The doctor suggested to clean the area with warm, mildly soapy water, rubbing the area to remove any existing adhesive residue and let it dry.He recommended to apply polysporin on wound and underneath gauze for the next couple of weeks and carefully wrap the wound in gauze, as needed.The reporter did not have polysporin and she applied some expired oxonol ointment with polymyxin b 10000 units.The mother reported the treatment seemed to work and the wound was healing.However, she said there was a good chance of scarring as there was significant blistering.

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 and 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.The product was manufactured per specification on (b)(6) 2018.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2019-00089.The same patient is represented in each medwatch.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 HYDROSEAL BANDAGES EXTRA LARGE
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• MDR Report Key: 8861279
• MDR Text Key: 153840440
• Report Number: 2214133-2019-00088
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 62600238207
• UDI-Public: (01)62600238207(10)0458C
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 62600238207
• Device Lot Number: 0458C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 54