MAUDE Adverse Event Report: COVIDIEN MONOSOF MONOFILAMENT NYLON 4-0 1.5 METRIC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2021

Event Type  Injury  

Event Description

Suture needle became detached from suture and fell into wound bed.

• Brand Name: MONOSOF MONOFILAMENT NYLON 4-0 1.5 METRIC
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12569365
• MDR Text Key: 274769899
• Report Number: MW5104354
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): Y
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 75