MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND ADVANCED HEALING BANDAGES; DRESSING, WOUND, OCCLUSIVE

Model Number 381371175338

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

Patient Problems Scar Tissue (2060); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided for reporting.This report is for (band aid brand kizu power pad unspecified ap not applicable rgebabkapa rgebabkapa).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).Lot # is not available.Udi #: (b)(4).Upc #: 381371175338 lot #: ni.Exp: ni.Device is not expected to be returned for manufacturer review/investigation.This report is for (band aid brand kizu power pad unspecified ap not applicable rgebabkapa rgebabkapa).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).Lot # is not available.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 med-watch, an additional follow-up med-watch will be filed as appropriate.

Event Description

A consumer, of unknown age or gender, reported an event with an unspecified band aid brand kizu power pad(kpp).The consumer had gotten a wound 3 weeks prior to this reporting.Although the consumer had been applying kpp for about 2 weeks, the wound gradually widened.The consumer visited a hospital and received unknown treatment.The consumer also alleges a scar.

• Brand Name: BAND AID BRAND ADVANCED HEALING 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: 11499463
• MDR Text Key: 244483392
• Report Number: 2214133-2021-00013
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381371175338
• UDI-Public: (01)381371175338(10)NI
• 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
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371175338
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention