MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE; GLOVES, STERILE

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  malfunction  

Event Description

In preparation for surgery sterile size 8 and 6.5 gloves were prepared.When the physician was going to don gloves he and the surgical scrub technician noted holes in both sets of gloves near the cuff.The gloves were replaced and saved.Per hospital, the manufacturer came today to be onsite for concerns.

Event Description

In preparation for surgery sterile size 8 and 6.5 gloves were prepared.When the physician was going to don gloves he and the surgical scrub technician noted holes in both sets of gloves near the cuff.The gloves were replaced and saved.Per hospital, the manufacturer came today to be onsite for concerns.

• Brand Name: MEDICHOICE
• Type of Device: GLOVES, STERILE
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC; 2301 robb drive; reno NV 89523
• MDR Report Key: 9266270
• MDR Text Key: 164628338
• Report Number: 9266270
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1