MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE SURGICAL PROTEXIS PI CLASSIC; SURGEON'S GLOVES

Catalog Number 2D72PL75X

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

Patient Problems Rash (2033); Tissue Damage (2104); Twitching (2172)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was not available so the device history record could not be reviewed.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.The protexis pi classic gloves passed the requirements of the primary skin irritation test per the technical service report.There have been no changes to the glove formulation or production process.The actual root cause could not be determined.The protexis pi classic 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

Physician assistant wore the glove for over a year and had no issues.Then on (b)(6) 2017 he developed symptoms that have been ongoing.Symptoms are a maculopapular rash that is severely pruritic that will eventually become very dry and cause cracking in his skin.The rash was diffuse on his wrists, hands and fingers, and did spread to his forearms, armpits, back and chest.He has seen dermatologists, an allergist/immunologist, had testing done, and used prednisone.

• Brand Name: GLOVE SURGICAL PROTEXIS PI CLASSIC
• 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: 7266782
• MDR Text Key: 99923889
• Report Number: 1423537-2018-00155
• 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 Catalogue Number: 2D72PL75X
• Device Lot Number: UNKNOWN
• 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
• 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