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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES EXTRA LARGE DRESSING, WOUND, OCCLUSIVE Back to Search Results
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.
 
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Brand NameBAND AID BRAND HYDROSEAL BANDAGES EXTRA LARGE
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
JOHNSON & JOHNSON CONSUMER INC
199 grandview road
skillman NJ 08558 9418
Manufacturer (Section G)
COLOPLAST
coloplast hungary kft.
h-4300 nyirbator
coloplast u.2
HU
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key8861279
MDR Text Key153840440
Report Number2214133-2019-00088
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
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 Received08/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number62600238207
Device Lot Number0458C
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/05/2019 Patient Sequence Number: 1
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