MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE, SURGICAL, NEOPRENE ESSENTIAL SIZE 7.5; SURGEON'S GLOVES

Catalog Number 2D73DS75

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Historical trending was done.As of the date of this filing, no sample has been received from the customer for evaluation.If in the future the sample is received, a follow up report will be filed.Based off of representative gloves, the neoprene essential gloves passed the requirements of the primary skin irritation test per the technical service report.The neoprene essential gloves have passed a series of tests prescribed by regulatory agencies for the intended use.However, the possibility of some individuals experiencing reactions to certain chemicals that are used during the manufacturing process cannot be ruled out.There is no action plan at this time, however we will continue to monitor complaints for any unfavorable trends, which might require further investigation.

Event Description

In early (b)(6) 2017 physician assistant started wearing only the neoprene essential gloves.An existing rash on his fingers and distal hands went away but the rash on his wrist and snuffbox area persisted and remained consistent since (b)(6).Symptoms are a maculopapular rash that is severely pruritic that becomes very dry and causes cracking in his skin.He has seen dermatologists, an allergist/immunologist, had testing done, and used prednisone.

• Brand Name: GLOVE, SURGICAL, NEOPRENE ESSENTIAL SIZE 7.5
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7266775
• MDR Text Key: 99920731
• Report Number: 1423537-2018-00154
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician Assistant
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 2D73DS75
• Device Lot Number: TS16100289
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 88