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

Model Number	30485
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE US LLC; 5550 peachtree parkway, suite 500; norcross GA 30092
• MDR Report Key: 9853247
• Report Number: 9853247
• Device Sequence Number: 2663760
• Product Code: KGO
• UDI-Device Identifier: 05060097930906
• UDI-Public: (01)05060097930906(17)220828(10)191671
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020
• Report Date (Section F): 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30485
• Device Catalogue Number: 30485
• Device Lot Number: 191671
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/13/2020