MAUDE Adverse Event Report: ETHICON, INC. ETHICON MONCRYL PLUS ANTIBACTERAI 4.0; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Problem Dull, Blunt (2407)

Patient Problem Laceration(s) (1946)

Event Date 07/27/2022

Event Type  Injury  

Event Description

The patient underwent a c-section.While the physician was closing the patient, the physician noticed the needle was not flowing smoothly through the tissue.The physician examined the needle and noticed that the end was blunted.The physician ordered an x-ray of the abdomen.Fda safety report id# (b)(4).

• Brand Name: ETHICON MONCRYL PLUS ANTIBACTERAI 4.0
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 15638617
• MDR Text Key: 302196877
• Report Number: MW5112758
• Device Sequence Number: 1
• Product Code: GAM
• 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: 10/17/2022

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: 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: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American