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

Catalog Number	2D73PM60
Health Effect - Clinical Codes	Irritation (1941); Pain (1994)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• MDR Report Key: 8604862
• Report Number: 1423537-2019-00317
• Device Sequence Number: 3030622
• Product Code: KGO
• UDI-Device Identifier: 10885380027260
• UDI-Public: 10885380027260
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2D73PM60
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR