MAUDE Adverse Event Report: COVIDIEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number SL-1653

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

Approximately two thirds of needle broke off in the dermis whil closing subcuticular layer.Incision reopened for exploration.Unable to locate needle fragment.Fragment visible on xray.Fragment retained in patient.

• Brand Name: POLYSORB
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13576818
• MDR Text Key: 285950580
• Report Number: 13576818
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2022,02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-1653
• Device Lot Number: DIG0077Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4745 DA
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White