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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDATECH PHARMA US / HELSINN HEALTHCARE SA GELCLAIR GEL PAP; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

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MIDATECH PHARMA US / HELSINN HEALTHCARE SA GELCLAIR GEL PAP; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC Back to Search Results
Lot Number 082811
Device Problem Insufficient Information (3190)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 08/31/2020
Event Type  Injury  
Event Description
Hospitalization.
 
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Brand Name
GELCLAIR GEL PAP
Type of Device
DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
Manufacturer (Section D)
MIDATECH PHARMA US / HELSINN HEALTHCARE SA
MDR Report Key10483251
MDR Text Key205514217
Report NumberMW5096390
Device Sequence Number1
Product Code MGQ
UDI-Device Identifier89141045602
UDI-Public89141-0456-02
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date02/28/2021
Device Lot Number082811
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
Patient Weight91
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