MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND CUSHION CARE SPORTS STRIP; TAPE AND BANDAGE, ADHESIVE

Model Number 381370047230

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

Patient Problems Pain (1994); Peeling (1999); Ulcer (2274); Impaired Healing (2378); Skin Tears (2516); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.Upc #: (b)(4), lot #: 3329b, exp: na; udi #: (b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).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 november 28, 2019.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 j&j band aid brand cushion care sports strip.The consumer was using the product for a cut on her toe.On (b)(6) 2020, upon trying to remove the bandage, it took off her skin and she was bleeding.The consumer sought medical attention and a health care professional removed the bandage.It took 12 minutes to be removed.The health care professional put some neosporin on the cuts that were bleeding and gave the consumer unknown medication.The consumer is still experiencing some bleeding.

Event Description

Consumer provided follow-up information on the event.Consumer still has a hole on her toe from where the skin got peeled off.

Manufacturer Narrative

Johnson & amp; 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 & amp; 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 & amp; johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & amp; johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.B5: as on overabundance of caution we are submitting this supplemental report.It is unknown if this is related to the consumer & apos; s initial injury prior to application of product or related to the event with the product.If information is obtained that was not available for the follow-up #1 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 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.Additional data: b5 - updated reporter verbatim.B7- updated consumer's height and allergy information.Investigation conclusion code: d15- in this case where the consumer reported experiencing a skin injury after using the product a single time on a cut, the reported sequelae over the next 2 years seems unlikely to be related to product use.If information is obtained that was not available for the follow-up #2 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received from the consumer on 03-may-2022: it was reported by the consumer that due to product use 2 years ago, she experienced the following: it took the whole bottom of her big toe off on the left foot and couldn¿t walk with shoes for the pain and have been unable to wear shoes for this length of time even can now.The consumer spent every other week at podiatrist.Four days after this happened the podiatrist was still pulling pieces of band-aid off her toe.It was reported that a toe was raw hear it is 2 years later still can¿t put weight on her toe.As per consumer, it formed an ulcer on big toe and can¿t be removed because there is only bone under ulcer, no skin so must leave scab on for now.The doctor opinion was that it usually takes a year to fall off on its own.The consumer reported that she has never experienced such pain and missed out of work for several weeks but had to work and endure the pain.The consumer also reported that she is most likely having to have surgery or possible losing her big toe on left foot.However, the doctor wants to see if it heals on its own and the patient just needs relief from the excruciating pain it has caused.It was also reported that it had to be compounded from pharmacy which only made the consumer¿s pain worse.She states that her mobility became very hard.

• Brand Name: J&J BAND AID BRAND CUSHION CARE SPORTS STRIP
• 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: 10223874
• MDR Text Key: 201255478
• Report Number: 8041154-2020-00015
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047230
• UDI-Public: (01)381370047230(10)3329B
• 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,Followup
• Report Date: 05/03/2022

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: 381370047230
• Device Lot Number: 3329B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/09/2020; 05/03/2022
• Supplement Dates FDA Received: 07/15/2020; 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 77 KG