MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED UNKNOWN PRODUCT-MED; SURGEON'S GLOVES

Model Number UNKNOWN PRODUCT-MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

Based on limited information provided at this time and no product code or product sample, we are unable to provide any further detail related to this report.

Event Description

Plaintiff alleges that from approximately 1994 to 2018, she was exposed to asbestos through her use of triflex gloves while working as a pathologist at (b)(6).

• Brand Name: UNKNOWN PRODUCT-MED
• 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 ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 8364874
• MDR Text Key: 136981291
• Report Number: 1423537-2019-00273
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other