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

Catalog Number 2D73EB80

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided, therefore the device history record could not be reviewed.The complaint sample was not available for evaluation, therefore an exact root cause could not be determined.Trending was done.Per historical testing, the protexis pi blue gloves passed the requirements of the primary skin irritation test per the technical service report.The protexis pi blue 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 used during the manufacturing process cannot be ruled out.We will continue to monitor complaints for any unfavorable trends, which might require further investigation.

Event Description

Scrub technician developed hand itching, redness, blisters and ulcers.Their symptoms started in february.They wore the gloves for approximately 1 year before developing symptoms.Steroids were followed by seeing a dermatologist and testing for allergies.Back to work 6 weeks later.Discontinued using the gloves.

• Brand Name: GLOVE SURGICAL PROTEXIS PI BLUE
• 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: 6876660
• MDR Text Key: 86639686
• Report Number: 1423537-2017-00125
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380027413
• UDI-Public: (01)10885380027413
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2D73EB80
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 113