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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE, US LLC BIOGEL SURGEONS; NON-POWDERED SURGEON'S GLOVE
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MOLNLYCKE HEALTH CARE, US LLC BIOGEL SURGEONS; NON-POWDERED SURGEON'S GLOVE Back to Search Results
Catalog Number 30480
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2020
Event Type  malfunction  
Event Description
A package of biogel gloves size 6 1/2 were opened to the surgical field and had 2 right handed gloves in the packaging, no left handed glove.No patients or staff were harmed in the opening of these gloves.When the issue was noticed another pair of gloves were opened to continue on with the surgery.Image is not the packaging from this event as it was thrown out and the caregiver did not record what the lot # was.Picture is the exact same product so it can be used as reference for the purpose of this report.
 
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Brand Name
BIOGEL SURGEONS
Type of Device
NON-POWDERED SURGEON'S GLOVE
Manufacturer (Section D)
MOLNLYCKE HEALTH CARE, US LLC
5445 triangle parkway suite 400
peachtree corners GA 30092
MDR Report Key10585797
MDR Text Key208538755
Report Number10585797
Device Sequence Number1
Product Code KGO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/23/2020
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
Device Operator No Information
Device Catalogue Number30480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2020
Event Location Hospital
Date Report to Manufacturer09/25/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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