MAUDE Adverse Event Report: UNKNOWN TITANIUM COIL; CLIP, IMPLANTABLE

Device Problem Defective Component (2292)

Patient Problem Blood Loss (2597)

Event Date 07/05/2019

Event Type  Injury  

Event Description

Nineteen months ago a titanium coil of my spleen was performed.On (b)(6) 2019 it began bleeding.My hemoglobin was 6.I was on vacation in (b)(6).I was transferred to a trauma hospital.A gel foam patching was performed, transfusions and icu stabilized me.A few days later i flew home to (b)(6) with a hemoglobin of 8 and will go to surgery this week to have a splenectomy.I want to know what company supplied the obvious defective titanium coil.Please respond asap (b)(6).I would like to hear from the fda before i contact my lawyer.(b)(6) bsn rn.Fda safety report id # (b)(4).

• Brand Name: TITANIUM COIL
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8823012
• MDR Text Key: 152321884
• Report Number: MW5088352
• Device Sequence Number: 1
• Product Code: FZP
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 63 YR
• Patient Weight: 59