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 No Code Available (3191)

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 1976 to 2006, in the course of her work as a nurse for various employers in (b)(6), plaintiff (b)(6) regularly and frequently used latex gloves manufactured, distributed, sold and supplied by the defendants.Upon information and belief, the use of these latex gloves exposed plaintiff (b)(6) to respirable asbestos fibers from asbestos-containing talc and/or talcum powder sold and/or distributed by defendants, causing her to develop mesothelioma.

• 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: 8364893
• MDR Text Key: 136982781
• Report Number: 1423537-2019-00274
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other