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 Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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, a3, a4, a5: patient identifier, patient age, gender, weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (1) range - adhesive bandages ap not applicable 0000rgebabapd.Device is not distributed in the united states but is similar to device marketed in the usa (band-aid unspecified usa notapplicable babgenusunsp babgenusunsp).Lot number - ni.D4: udi, upc, lot number and expiration date are not available.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.Device history records review could not be completed without lot number.H6: health effect clinical code: e2402 refers to consumer "intentional misuse/off-label use" of the product.This is 1 of 2 med-watches being submitted as two devices such as range - adhesive bandages and band aid brand kizu power pad unspecified were involved in this event.See medwatch 2214133-2023-00029 for band aid brand kizu power pad unspecified.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with range adhesive bandage strip which was applied to stop bleeding from a cut caused by a kitchen knife.Consumer reported that the bleeding was stopped after product use.On the night of the same date, the consumer replaced the strip with a scratch power pad.The next day bleeding occurred from the wound and did not stop easily.Consumer went to the hospital and the wound was treated and stitched/sewn up.This is 1 of 2 med-watches being submitted as two devices such as range - adhesive bandages and band aid brand kizu power pad unspecified were involved in this event.See medwatch 2214133-2023-00029 for band aid brand kizu power pad unspecified.The same patient is represented in each medwatch.

• Brand Name: RANGE - ADHESIVE BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 17744653
• MDR Text Key: 323390664
• Report Number: 2214133-2023-00028
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/23/2023

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention