MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER; TAPE AND BANDAGE, ADHESIVE

Model Number 381370047681

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

Patient Problems Scar Tissue (2060); Impaired Healing (2378); Skin Tears (2516); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/15/2023

Event Type  Injury  

Event Description

A 62-year-old female consumer reported that on (b)(6) 2023 she used a band-aid brand tru stay sheer large adhesive pad to cover an abscess on the stomach.When the band aid was removed, the adhesive on product removed the tops of the blisters and was very painful and bled.It was reported that when the consumer took the product off ¿the square area where all the adhesive was, it ripped all the blister tops off and made huge wounds all around that were healing¿.It was also reported that ¿it takes 10 to 14 days to heal the blister.Consumer reported she went to see the doctor and was prescribed an unknown antibiotic that was good for skin problems as the wounds were too red and the doctor did not like the way they looked.Consumer reported she ended up taking the unknown antibiotic which gave her side effects, on her tendons, and she went to the emergency room.The consumer went to the hospital twice and also went to emergency room and was treated with an antibiotic (route not specified; interpreted as oral/topical).The wounds have healed but states she has scars.

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.A4, a5: weight, ethnicity and race were not available for reporting.D1, d2, d3, d4: this report is for one band-aid brand tru stay sheer large adhesive pad 10ct usa 381370047681 381370047681usa 381370047681usa, lot number 0623b.D4: (01)381370047681(10)0623b upc #: 381370047681 expiration date: na lot #: 0623b d10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.H6: health effect clinical code: e1721 also refers to consumer alleged about "it ripped all blister tops off and made huge wounds all around that were healing, pain and too red".E2402 refers to consumer "intentional misuse/off-label use" of the product.If information is obtained that was not available for the initial medwatch, an additional follow- up medwatch will be filed as appropriate.

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.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on march 03, 2023.Raw material and component records were reviewed and were found acceptable.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 17886187
• MDR Text Key: 325088885
• Report Number: 8041154-2023-00026
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047681
• UDI-Public: (01)381370047681(10)0623B
• 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: 10/09/2023

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: 381370047681
• Device Lot Number: 0623B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female