MAUDE Adverse Event Report: BD BECKTON DICKINSON AND COMPAN / BARD ACCESS SYSTEMS, INC. STATLOCK FOLEY STABILIZATION DEVICE; TAPE AND BANDAGE, ADHESIVE

Device Problems Device Appears to Trigger Rejection (1524); Device Ingredient or Reagent Problem (2910)

Patient Problems Hypersensitivity/Allergic reaction (1907); Contact Dermatitis (4546)

Event Date 08/13/2021

Event Type  Injury  

Event Description

Acute and severe allergic reaction (contact dermatitis) to adhesive.Fda safety report id # (b)(4).

• Brand Name: STATLOCK FOLEY STABILIZATION DEVICE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): BD BECKTON DICKINSON AND COMPAN / BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 12342767
• MDR Text Key: 267560026
• Report Number: MW5103340
• Device Sequence Number: 1
• Product Code: KGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/16/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73