MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SYNTHETIC POLYISOPRENE SURGICAL GLOVE; SURGEON'S GLOVES

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

Surgical size 7 glove with holes.

• Brand Name: SYNTHETIC POLYISOPRENE SURGICAL GLOVE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 12252430
• MDR Text Key: 264543143
• Report Number: MW5102856
• Device Sequence Number: 1
• Product Code: KGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1