MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE US LLC SURGICAL GLOVE BIOGEL SURGEONS SIZE; SURGEON'S GLOVES

Model Number 30485

Device Problems Device Contamination with Body Fluid (2317); Packaging Problem (3007)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

Molnlycke biogel surgeons natural rubber latex surgical gloves, size 8 1/2, ref 30485, exp 08/28/2022, lot 191671 - opened outer package and long dark hair seen within the package.Packaging and hair saved; no patient exposure; no contamination of field.

• Brand Name: SURGICAL GLOVE BIOGEL SURGEONS SIZE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE US LLC; 5550 peachtree parkway, suite 500; norcross GA 30092
• MDR Report Key: 9853247
• MDR Text Key: 184077267
• Report Number: 9853247
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 05060097930906
• UDI-Public: (01)05060097930906(17)220828(10)191671
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30485
• Device Catalogue Number: 30485
• Device Lot Number: 191671
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1