MAUDE Adverse Event Report: ETHICON, INC. SURGICAL ; AGENT, ABSORBABLE, HEMOSTATIC, NON-COLLAGEN BASED

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hemorrhage/Bleeding (1888); Paralysis (1997)

Event Date 03/07/2020

Event Type  Injury  

Event Description

Surgical utilized intraoperatively for vessel bleeding.Left in for hemostasis and closed.Surgical migrated to spinal column and caused permanent damage and paralysis to pt.Fda safety report id# (b)(4).

• Brand Name: SURGICAL
• Type of Device: AGENT, ABSORBABLE, HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON, INC. ; somerville NJ 08876
• MDR Report Key: 9828894
• MDR Text Key: 183736901
• Report Number: MW5093717
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 54 YR
• Patient Weight: 101