MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND ADVANCED HEALING BANDAGES; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Cellulitis (1768); Skin Tears (2516); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.This report is for one (band aid brand advanced healing bandages unspecified ap notapplicable babahbunspecapa babahbunspecapa, lot/ctrl # n/a).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).Lot number was 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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A daughter reported an event for her father regarding unspecified band aid brand advanced healing bandage.The consumer is male and 93 years old.The consumer¿s daughter reported that her father has very fragile skin.On an unspecified date, an undisclosed person applied unspecified band aid brand advanced healing bandage on the consumer¿s wound.The location of the wound was not reported.On an unspecified date, the consumer developed cellulitis while the bandage was in use.On an unspecified date, the consumer was taken to hospital where saline solution was applied to try and remove the bandage with minimal success.Another liquid (unspecified) was applied to dissolve the adhesive.Approximately half of the bandage was able to be removed, however the skin was damaged during the removal and the doctors stopped trying to remove it further.The consumer stated that a large skin flap was left behind.At the time of the call, the patient was waiting to be reviewed by the plastic surgical team to discuss removal of the remaining product.Outcome of the event is unknown.

• Brand Name: BAND AID BRAND ADVANCED HEALING BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• 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, shanghai ; HU
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 15567137
• MDR Text Key: 301480761
• Report Number: 2214133-2022-00045
• Device Sequence Number: 1
• Product Code: KGX
• 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
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Sex: Male