MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND-AID HYDRO-SEAL UNSPECIFIED; DRESSING, WOUND, OCCLUSIVE

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

Patient Problems Unspecified Infection (1930); Pain (1994); Scarring (2061)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one (1) band-aid unspecified can (unspecified band-aid brand hydroseal bandage).Lot # and udi # are not available.Device is not distributed in the united states but is similar to device marketed in the usa (band-aid hydroseal unspecified usa).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 hydroseal unspecified usa).Device evaluation 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, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event using band-aid brand hydroseal bandage.On an unspecified day, the consumer used a band-aid brand hydroseal bandage to avoid a scar forming from a small scrape on her shin.Prior to use, she disinfected the wound and the area.After applying the bandage, the white bump formed as expected.However, when the bump started to feel a little painful, the consumer decided to remove the bandage and inspect the wound.The consumer stated the wound looked possibly infected and she was sure it would leave a big scar.As the pain at the site increased, the wound looked even more infected and the consumer started to worry about osteomyelitis.She consulted a doctor, who diagnosed her with infection/cellulitis, and prescribed an unspecified antibiotic.On (b)(6) 2020 and (b)(6) 2020, the consumer said she had ¿a huge scar on her leg¿ and would require consultations, treatments as well as the use of ¿scar away¿ products.No additional details were provided.

• Brand Name: BAND-AID HYDRO-SEAL UNSPECIFIED
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 -941; CA 08558-9418
• Manufacturer (Section G): COLOPLAST A/S; holtedam 1; hovedsaden DK-30 50; DA DK-3050
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9867967
• MDR Text Key: 196479520
• Report Number: 2214133-2020-00011
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• 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: 02/26/2020
• 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