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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BOVINE PERICARDIUM MESH, SURGICAL

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BAXTER HEALTHCARE CORPORATION BOVINE PERICARDIUM MESH, SURGICAL Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Headache (1880); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Test Result (2695)
Event Date 11/09/2012
Event Type  Injury  
Event Description
Patient went in for chiari decompression surgery where c-1 of the spine was removed. The patient states the doctors performed a complete craniotomy without her authorization. She was later informed that the pericardium mesh was used to close the dura. Patient reports she has been diagnosed with adrenal neoplasm, bulging of the cervical spine, vitamin d deficiency, bulging disc, degenerative disc disease, osteoarthritis, chronic migraine, pituitary tumor, as well as spinal compression. She reports experiencing ptsd, and attending rehab for depression and anxiety. Since the surgery her blood levels have been abnormal and can no longer have children due to producing testosterone. The patient states she is in constant agony, yet the doctors who performed surgery refuse to treat or follow up with her.
 
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Brand NameBOVINE PERICARDIUM
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key6773346
MDR Text Key82160893
Report NumberMW5071417
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/17/2017
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
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