MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC RANGE - ADHESIVE BANDAGES; DRESSING, WOUND, OCCLUSIVE

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

Patient Problems Purulent Discharge (1812); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided for reporting.This report is for (range - adhesive bandages ap not applicable 0000rgebabapd 0000rgebabapd).Upc#, and udi # is not available.Device is not distributed in the united states, but is similar to device marketed in the usa (band-aid unspecified usa babgenus).Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states but is similar to device marketed in the usa (band- aid unspecified usa babgenus).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.If information is obtained that was not available for the initial medwatch, an additional follow- up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with unspecified band-aid.A consumer experienced dryness and peeling skin on the heel of foot.Consumer had been applying band-aid, but the inflammation became worse, for which the consumer visited a dermatologist about a month and 10 days prior to this reporting.Since the wound was suppurative, an antibiotic ointment was prescribed, and treatment of the wound was changed to the ointment and gauze.About 10 days later, the prescription was changed from the antibiotic ointment to an ointment in a tube that forms a film.However, the wound did not get better, so the prescription was changed to a petrolatum product called propeto.A different type of bandage was applied by physician's instruction from (b)(6) 2021.On the following day ((b)(6) 2021), as the exudate was overflowing, the consumer replaced the strip with a new one.The consumer stated that the wound looked pink.Next hospital visit was scheduled on (b)(6) 2021.

• Brand Name: RANGE - ADHESIVE BANDAGES
• Type of Device: DRESSING, 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 Key: 12869117
• MDR Text Key: 285945374
• Report Number: 2214133-2021-00049
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/17/2021

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/24/2021
• 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