MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB VARIETY PACK 30S USA 381370048480; ADHESIVE BANDAGES

Model Number 381370048480

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

Patient Problems Ischemia (1942); Pain (1994); Peeling (1999)

Event Date 05/19/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ethnicity: patient ethnicity and race was not provided for reporting.Upc #: (b)(4), lot #: 2918b, udi #: (b)(4).Device available for evaluation: device is not expected to be returned for manufacturer review/investigation concomitant products: start date, frequency and last used date: metoprolol 50mg daily, for blood pressure.Ranitidine 150 mg, for reflux.Dicyclomine 10mg daily, for irritable bowel.Hydrochlorothiazide 25 mg, for high blood pressure.Amlodipine & valsartan 320mg, for high blood pressure.Sentol lotion.Plus daily b12 and vitamine e.Device evaluated by mfr, manufacture date: 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.Manufacturing date is 10/18/2018.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A caretaker reported an event with an unknown band-aid from bab variety pack 30s.The caretaker alleges that the skin was removed from her mother's leg and caused severe trauma.The consumer¿s skin ripped off with a laceration and the product was very hard to pull off of the skin, which was painful.It was bleeding profusely to the point that it would not stop.The consumer sought medical treatment.A visiting nurse came on an emergency visit and wrapped and elevated the leg.A few days later, a specialist examined the area of trauma, numbed it and applied larger, occlusive, medicated bandages.The doctor recommended using the given bandages, keeping the area covered and perform a follow up visit.The consumer has not recovered from the symptoms and the area is still irritated, red and bleeding.

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.Concomitant medical products: concomitant products: start date, frequency and last used date: samlodipine 320mg, besylate valsartan 320mg, for high blood pressure the consumer has reported a bab variety pack 30s usa 381370048480 (lot 2918b) where the specific bab that was used is unknown.Below is the list of all possible products in the variety pack.Babab 5/8" cushion-care sport strip (foam) babab 1" clear waterblock babab 1" tough strip (heavy duty) if information is obtained that was not available for the follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BAB VARIETY PACK 30S USA 381370048480
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 8709349
• MDR Text Key: 148403590
• Report Number: 8041154-2019-00058
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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: 381370048480
• Device Lot Number: 2918B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/03/2019
• Patient Sequence Number: 1
• Treatment: AMLODIPINE VALSARTAN; BESYLATE VALSARTAN; DICYCLOMINE; HYDROCHLOROTHIAZIDE; METOPOROLO; RANITIDINE; SAMLODIPINE; SENTOL LOTION
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 59