MAUDE Adverse Event Report: ANSELL HEALTHCARE PRODUCTS LLC MEDICHOICE SURGICAL GLOVES; SURGEON'S GLOVES

Model Number SGL95060

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/14/2019

Event Type  malfunction  

Event Description

At 0900: glove was put on the surgeon at the beginning of the case and right away noted a large hole in the ring finger tip.Surgeon had to change his gown and rescrub.At 1356: while assisting surgeon in donning sterile gloves for procedure the surgical scrub tech noted that one of the gloves had a hole in it.Manufacturer response for surgical gloves, medichoice (per site reporter).Has been on site to discuss previous issues with gloves.

• Brand Name: MEDICHOICE SURGICAL GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): ANSELL HEALTHCARE PRODUCTS LLC; 2301 robb drive; reno NV 89523
• MDR Report Key: 9382894
• MDR Text Key: 168295272
• Report Number: 9382894
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGL95060
• Device Catalogue Number: SGL95060
• Device Lot Number: 1808070705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1