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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX ONLAY; COLLAGEN DURA SUBSTITUTE MEMBRANE
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COLLAGEN MATRIX, INC. DURAMATRIX ONLAY; COLLAGEN DURA SUBSTITUTE MEMBRANE Back to Search Results
Model Number CDSLM33
Device Problem Degraded (1153)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 03/10/2022
Event Type  Injury  
Event Description
It was reported that a surgeon used duramatrix during a suboccipital craniectomy and reported that the dura substitute dissolved and they had to remove it and place a lumbar drain.Since there was not a tight seal using the duramatrix, csf was able to leak through.The product was replaced with duragen and discarded.
 
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Brand Name
DURAMATRIX ONLAY
Type of Device
COLLAGEN DURA SUBSTITUTE MEMBRANE
Manufacturer (Section D)
COLLAGEN MATRIX, INC.
15 thornton road
oakland NJ 07436
Manufacturer (Section G)
COLLAGEN MATRIX, INC.
15 thornton road
oakland NJ 07436
Manufacturer Contact
peggy hansen
15 thornton road
oakland, NJ 07436
MDR Report Key14113830
MDR Text Key289286307
Report Number2249852-2022-00002
Device Sequence Number1
Product Code GXQ
UDI-Device Identifier00813954020266
UDI-Public00813954020266
Combination Product (y/n)N
PMA/PMN Number
K061487
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date01/31/2024
Device Model NumberCDSLM33
Device Catalogue NumberCDSLM33
Device Lot Number2101272022
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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