MAUDE Adverse Event Report: COOK MEDICAL LLC GUNTHER TULIP IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number DENMARK EUROPE

Device Problems Partial Blockage (1065); Material Fragmentation (1261)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); High Blood Pressure/ Hypertension (1908); Pain (1994); Scar Tissue (2060); Skin Discoloration (2074); Swelling (2091)

Event Date 07/17/2014

Event Type  Injury  

Event Description

Discovered by one h p.Referred to (b)(6), dr.(b)(6), thrombosis if ivc, 100% occluded, embedded, fractured, lumbar body l2 infused with fractured strut of gunther tulip ivc filter cook medical.My physician a cook medical paid spokesperson.A cook medical compensated physician, grants, travel, meals, honorarium, product review.I was denied treatment, denied diagnoses, denied correct medical coding, taking 6 months to remove urgent referral, no anticoagulation, false medical documenting, to state my symptoms of severe back pain, swelling of ankles, purple veined skin "in his professional opinion not related to the filter, spelling incorrectly embedded, coding as 53.99 fitting adjust other, instead of open extraction with icu admittance severe complication, leaving 13 inch scar across abdomen, loss of bodily functions, severe post op back pain, portal hypertension, medical provider to deny further care, deny access to medical records, deny amending of records.Creating false medical records to prevent causation of device sponsor cook medical, 1/31.When is enough, i have been denied care, i have been silenced, ignoring fda recommendation 'remove ivc filter as soon as medically possible.' fda refusing to enforce warnings, allowing paying pharmaceutical companies to get away with pharmaceutical raping of patients, taking no action to protect.Fda safety report id # (b)(4).

• Brand Name: GUNTHER TULIP IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL LLC
• MDR Report Key: 10091658
• MDR Text Key: 192715973
• Report Number: MW5094682
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DENMARK EUROPE
• Device Catalogue Number: FEMORAL
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 48 YR
• Patient Weight: 72