MAUDE Adverse Event Report: CODMAN NEURO SURGICAL PATTIES

Model Number 1/2 X 1-1/2

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Event Description

Surgical pattie 1/2 x 1 1/2 broke inside of patient.Pieces gathered to form 1/2 x 1 1/2 pattie.No harm to patient.

• Brand Name: SURGICAL PATTIES
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): CODMAN NEURO; raynham MA 02767
• MDR Report Key: 5584307
• MDR Text Key: 42955810
• Report Number: MW5061748
• Device Sequence Number: 1
• Product Code: HBA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1/2 X 1-1/2
• Device Catalogue Number: 80-1404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 98