MAUDE Adverse Event Report: COVIDIEN MAXON 2-0; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number R#88866233-51

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 08/03/2022

Event Type  Injury  

Event Description

While dr.Was closing, the needle broke off the suture and was unable to be seen in the patients subcutaneous tissue.The surgeon had to look for a while until he was able to retrieve the maxon 2-0 suture.Subcutaneous tissue had to be removed to locate and retrieve needle.Then the surgeon continued with closing.Fda safety report id# (b)(4).

• Brand Name: MAXON 2-0
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 15183590
• MDR Text Key: 297511262
• Report Number: MW5111311
• 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: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R#88866233-51
• Device Lot Number: D1L1809Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White