MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC RANGE - ADHESIVE BANDAGES; DRESSING, WOUND, OCCLUSIVE

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 Date 12/07/2021

Event Type  Injury  

Event Description

A consumer reported an event with an unknown band aid bandage.On (b)(6) 2021, the consumer received a wound from a shaver.As the area swelled and became like a wart, the consumer applied the unknown band-aid bandage.The consumer scratched it and it bled and the bleeding would not stop.Since the hospital was closed and the bleeding did not stop, the consumer consulted a pharmacist at a pharmacy and applied terramycin (oxytetracycline hydrochloride/polymixin b sulfate) and placed band-aid on it.On the day of this reporting, the bleeding stopped and the event has resolved.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for (range - adhesive bandages ap not applicable 0000rgebabapd).Upc#, and udi # is not available.Device is not distributed in the united states, but is similar to device marketed in the usa (band-aid unspecified usa babgenus).Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa (band- aid unspecified usa babgenus).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.(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: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 13060078
• MDR Text Key: 282615136
• Report Number: 2214133-2021-00053
• Device Sequence Number: 1
• Product Code: NAD
• 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: 12/08/2021

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: 12/08/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention