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

Model Number	GL-181
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, on (b)(6), the suture was used during surgery.The patient was discharged on (b)(6) with a small amount of exudate at the wound site.Multiple follow-up visits to the hospital showed no improvement.On (b)(6), during another follow-up, a portion of the external suture was removed.A suture reaction was considered after implantation, likely due to suture rejection, which resulted in slow absorption.Although part of the external suture was removed, the deep suture could not be extracted.Purulent discharge and scabbing, along with subcutaneous pus accumulation, were observed on the right index and ring fingers.Wound healing was poor, and the suture remained unabsorbed for more than one month.
Event or Problem Description
According to the reporter, on october 8, the suture was used during subcutaneous suturing of the finger tendons surgery.The patient was discharged on october 28 with a small amount of exudate at the wound site.Multiple follow-up visits to the hospital showed no improvement.On november 18, during another follow-up, a portion of the external suture was removed.A suture reaction was considered after implantation, likely due to suture rejection, which resulted in slow absorption.Although part of the external suture was removed, the deep suture could not be extracted.Purulent discharge and scabbing, along with subcutaneous pus accumulation, were observed on the right index and ring fingers.Wound healing was poor, and the suture remained unabsorbed for more than one month.
Additional Manufacturer Narrative
Additional information: b5, e1 (initial reporter, street1, phone number), g3, medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23827607
• Report Number: 1219930-2025-05846
• Device Sequence Number: 8954324
• Product Code: GAM
• UDI-Device Identifier: 10884521045057
• UDI-Public: (01)10884521045057(17)300531(10)A5F1872Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GL-181
• Device Catalogue Number: GL-181
• Device Lot Number: A5F1872Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female