MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC RANGE - ADHESIVE BANDAGES; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Itching Sensation (1943); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/10/2022

Event Type  Injury  

Event Description

The pharmacy reported an event with unspecified adhesive bandage.The pharmacy reported that on (b)(6) 2022, consumer came to pharmacy to buy bandage due to finger abrasion and attached it to the affected area.On (b)(6) 2022, consumer came back to pharmacy again as consumer developed skin pruritus and erythema at the bandage application site on the finger.The pharmacist advised consumer to stop using the product and dispensed piyanping (interpreted as unspecified cream) for the erythema.It was also reported that, consumer was having rash and itching symptoms after applying the product.There is no additional information with regards to outcome for this consumer.

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.This report is for one (range - adhesive bandages ap not applicable 0000rgebabapd 0000rgebabapd, lot/ctrl # n/a).Device is not distributed in the united states, but is similar to device marketed in the usa (band-aid unspecified usa not applicable babgenusunsp babgenusunsp).Reported lot number is invalid.Upc #, lot # 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 valid lot number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RANGE - ADHESIVE BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): SKILLMAN CONTRACT; 199 grandview road; skillman NJ 08558 9418
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 15566392
• MDR Text Key: 301631563
• Report Number: 2214133-2022-00044
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2022

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
• Event Location: Other
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female