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

Catalog Number 2D73EB75

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot number was not available so the device history record could not be reviewed.Historical trending was done, and this is the first event involving this catalog number for this defect.No sample was available for evaluation, therefore an exact root cause could not be determined.Previously the product 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 of this nature that might require further investigation.

Event Description

Surgical technician developed eczematous contact type dermatitis.She sought medical care and was prescribed steroid cream, antibacterial cream and oral steroids.

• 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; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5812517
• MDR Text Key: 50118423
• Report Number: 1423537-2016-00033
• 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: Other
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 2D73EB75
• Device Lot Number: NO LOT GIVEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR