MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND-AID UNSPECIFIED; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Impaired Healing (2378); Skin Tears (2516); Skin Infection (4544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A female consumer reported an event with unspecified band aid bandage.The consumer had pre-existing history of squamous cell skin cancer on her leg and was having a hard time healing.The area of issue was on the inside of her shin; therefore, all her clothes were touching it, and the band-aid kept pulling off the scab.It was reported that the consumer had a very hard time healing it and it got infected and had to be on an unknown antibiotic three times.

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.A1, a2, a4 and a5: patient identifier, age, weight and ethnicity were not provided for reporting.D1, d2, d3, d4: this report is for one (1) band-aid unspecified usa not applicable babgenusunsp babgenusunsp, lot number ni.D4: udi, upc, lot number and expiration date are not available.D9: 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.Device history records review could not be completed without lot number.H6: health effect clinical code: e1721 also refers to consumer alleged ¿kept pulling scab off.¿ e1707 also refers to consumer alleged ¿hard time healing it.¿ e2402 refers to consumer "intentional misuse/off-label use" of the product.This even was reported as an overabundance of caution.It was reported that consumer ¿recently had squamous cell skin cancer on leg and was having a hard time healing it¿.Bpc reply inconclusive on product usage details and medical history.Based on limited information available, it was interpreted that the product was applied on a pre-existing healing lesion (interpreted as misuse) and it kept ¿pulling off the scab¿ (interpreted as and coded to skin tear) and the consumer had ¿very hard time healing it¿ (interpreted as and coded to impaired healing) which subsequently also got infected (coded to skin infection).No health care professional consult reported, the consumer reportedly ¿had to be on an anabiotic three times¿ (¿anabiotic¿ was interpreted as antibiotic; route not specified; interpreted as oral/topical).There was not any direct attribution of ¿squamous cell skin cancer¿ to product usage and was thus interpreted as pre-existing medical history and will be reassessed on receipt of further details of events attributed to product if any.No hospitalization, no significant intervention reported.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BAND-AID UNSPECIFIED
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ
• Manufacturer (Section G): SKILLMAN CONTRACT; 199 grandview road; skillman NJ 08558 9418
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18578803
• MDR Text Key: 333668140
• Report Number: 2214133-2024-00003
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female