MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB TOUGH STRIPS; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Peeling (1999)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age at time of event, weight and ethnicity were not provided for reporting.Report is for one (1) band-aid tough strips unspecified usa not applicable batgztusunsp, lot number n/a.Upc, lot number and udi are 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer¿s attorney reported an event with band-aid tough strip.Consumer used product for 23 hours on his left arm near a burn and a 2 inch by 2 inch piece of the skin of his arm peeled off, causing excruciating pain and doctor visits.When consumer tried to peel of product off his arm, the skin (very deep) will peel off with product.No additional information is known at this time.

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.Additional information: a1: patient date of birth ¿ (b)(6) 1956.B5: additional information received from consumer on october 26, 2021, and it was reported that consumer was also experiencing burn during removal of bab tough strips, 10 count.No additional information is known at this time.D10: concomitant medical products: rosuvastatin calcium; losartan potassium; bupropion; venlafaxine; quetiapine fumarate.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.

Event Description

Additional information received from consumer on october 26, 2021, and it was reported that consumer was also experiencing burn during removal of bab tough strips, 10 count and tender to palpation erythema.Additionally, it was reported that consumer was healing well and started mupirocin 2% external ointment for treatment.No additional information is known at this time.

• Brand Name: BAB 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): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 12527052
• MDR Text Key: 273761386
• Report Number: 8041154-2021-00034
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: BUPROPION; LOSARTAN POTASSIUM; QUETIAPINE FUMARATE; ROSUVASTATIN CALCIUM; VENLAFAXINE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male