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

Catalog Number	2D73EB80
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Reaction (2414)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Scrub technician developed itching, erythema, skin dryness with breaks in finger joints.Their symptoms started approximately the end of (b)(6).They wore the gloves 8-10 months prior to having a reaction.The employee health nurse referred the technician out for evaluation.They were unable to scrub for 4 weeks and currently are pending return to full duty.They discontinued using the gloves.

• Brand Name: GLOVE SURGICAL PROTEXIS PI BLUE
• 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: 6878682
• Report Number: 1423537-2017-00126
• Device Sequence Number: 116794
• Product Code: KGO
• UDI-Device Identifier: 10885380027413
• UDI-Public: (01)10885380027413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 2D73EB80
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Weight: 77