MAUDE Adverse Event Report: MEDLINE FOLEY CATHETER SILICONE ELASTOMER COATED (LATEX)

Model Number 16 FR 5-10 CC

Device Problems Improper or Incorrect Procedure or Method (2017); Packaging Problem (3007)

Patient Problems Asthma (1726); Hypersensitivity/Allergic reaction (1907); Pain (1994); Urticaria (2278); Discomfort (2330); Reaction (2414)

Event Date 04/11/2016

Event Type  Injury  

Event Description

The home registered nurse though a medline foley catheter was safe to use because it is latex, it is labelled."foley catheter silicone elastomer coated (latex)".Because of this labeling, she and her nursing supervisor though because it is "coated" it should be safe to use even though i have a latex allergy.In small print on the package it reads, "caution: this product contains natural latex polymer which could cause allergic reaction." this caution is in small print and is not prominent.I do not believe it is adequate warning and that the registered nurses were confused and thought ok i think is evidence enough that the labeling is not adequate.The use of this product resulted in a moderate latex allergic reaction including blisters, hives, asthma flare up, ongoing pain and discomfort and has required medication, doctor consultations, changing treatment plans and hopefully not anything further.I also made contact with the manufacturer in an attempt to find out what exactly this is and let them know that staff at this home health care agency believe this is safe with latex allergies due to the product being "coated" per description.The manufacturer quickly acknowledged this product was not recommended to be used with those with "true" latex allergies.I am having to wait until the blisters from this latex allergic reaction heal to do the lab test that required the use of a foley catheter for me.This product needs to have labeling that is much more clear.

• Brand Name: FOLEY CATHETER SILICONE ELASTOMER COATED (LATEX)
• Type of Device: FOLEY CATHETER SILICONE ELASTOMER COATED (LATEX)
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 5584190
• MDR Text Key: 42949269
• Report Number: MW5061728
• Device Sequence Number: 1
• Product Code: EZL
• 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: 04/13/2016

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: 16 FR 5-10 CC
• Device Catalogue Number: DYND11756
• Device Lot Number: 1405020502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 145