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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL PI INIDCATOR UNDERGLOVE; POWDERED LATEX SURGEON'S GLOVES

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MOLNLYCKE HEALTH CARE BIOGEL PI INIDCATOR UNDERGLOVE; POWDERED LATEX SURGEON'S GLOVES Back to Search Results
Model Number SIZE: 7.5
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2017
Event Type  malfunction  
Event Description
Sterile glove set opened for surgeon's use.A dead fly was found inside the sterile packaging.
 
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Brand Name
BIOGEL PI INIDCATOR UNDERGLOVE
Type of Device
POWDERED LATEX SURGEON'S GLOVES
Manufacturer (Section D)
MOLNLYCKE HEALTH CARE
5550 peachtree pkwy.
ste. 500
norcross GA 30092
MDR Report Key6510676
MDR Text Key73346882
Report Number6510676
Device Sequence Number1
Product Code KGO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSIZE: 7.5
Device Catalogue Number41675-02
Device Lot Number16K030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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