MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND FLEXIBLE FABRIC BANDAGES TOUGH STRIPS; TAPE AND BANDAGE, ADHESIVE

Model Number 9300607179125

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

Patient Problem Peeling (1999)

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 and 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.Patient date of birth, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand tough strips regular 20ct (b)(4)).Device is not distributed in the united states, but is similar to device marketed in the usa (bab tough strips (b)(4)).Udi #: (b)(4).Upc: 9300607179125; lot number: ni.Expiration date: na.Device is not expected to be returned for manufacturer review/investigation.This report is for (band aid brand tough strips regular (b)(4)).Device is not distributed in the united states, but is similar to device marketed in the usa (bab tough strips (b)(4)).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, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event with band aid brand tough strips regular.The consumer used one bandage on (b)(6) 2021 to cover a wound and did not notice the instruction (under directions) that the dressing should be changed daily.The consumer left if for 3 days and when she tried to remove it today, it tore off healthy skin as it was so firmly stuck.She had to go to her doctor to have it removed.Consumer required a new dressing to cover the open wound caused by the bandage.

• Brand Name: BAND AID BRAND FLEXIBLE FABRIC BANDAGES TOUGH STRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): SHANGHAI JOHNSON & JOHNSON LTD; 120 nan ya road; minghang, shanghai
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 12533701
• MDR Text Key: 273373354
• Report Number: 1000599868-2021-00013
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 9300607179125
• UDI-Public: (01)9300607179125(10)NI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/13/2021

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
• Device Model Number: 9300607179125
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/27/2021
• 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): Required Intervention