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

Catalog Number 2D73PM60

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Pain (1994)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, the device history record could not be reviewed.Since the complaint sample was not available for evaluation an exact root cause could not be determined, however the healthcare assistant did test positive for an allergy to accelerators.Per historical testing, this glove passed the requirements of the primary skin irritation test per the technical service report.The protexis pi micro gloves have passed a series of tests prescribed by regulatory agencies for the intended use.However, the possibility of an individual experiencing reactions to certain chemicals used during the manufacturing process cannot be ruled out.Although no trends for this issue were noted during the last twelve months, we will continue to monitor complaints for any unfavorable trends.

Event Description

Healthcare assistant initially developed irritation on backs of hands, followed by blistering of fingers and palms of hands.Hands and finger tips developed deep cracks, and irritation spread along forearms; he also had significant pain.He was seen initially by a gp and prescribed steroid creams.He was also seen by occupational health and referred for a dermatology consultation and skin tests which showed an allergy to carbamix and an accelerator.Six weeks were required to heal.He currently needs to wear cotton gloves under all gloves.

• Brand Name: GLOVE SURGICAL PROTEXIS PI MICRO
• 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 ; 8478874151
• MDR Report Key: 8604862
• MDR Text Key: 144872923
• Report Number: 1423537-2019-00317
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380027260
• UDI-Public: 10885380027260
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2D73PM60
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR