MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	CL-922
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Necrosis (1971); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/25/2025
Type of Reportable Event	Serious Injury
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, the patient gave birth vaginally on (b)(6) 2025, after episiotomy, the wound was sutured with synthetic absorbable surgical suture.On (b)(6) 2025, the patient experienced persistent perineal pain, wound redness and swelling after delivery.The doctor found that suppuration occurred at the perineal suture.It was noted that there was rejection of synthetic absorbable surgical suture, which was not absorbed, caused an acute inflammatory response.After anesthesia, the suture was removed from the perineum, the wound was cleaned, the pus cavity was cleaned, and the necrotic tissue was removed.Metronidazole sodium chloride injection and cefuroxime sodium + 0.9% sodium chloride injection were used for intravenous antibacterial treatment, and rivanol solution was used for wet compress disinfection.On (b)(6) 2025, the perineal laceration was sutured again in the hospital, and the wound was sutured with non-absorbable surgical suture, and the suture was removed after five days.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21547178
• Report Number: 1219930-2025-01126
• Device Sequence Number: 7642939
• Product Code: GAM
• UDI-Device Identifier: 10884521043398
• UDI-Public: 10884521043398
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: CL-922
• Device Catalogue Number: CL-922
• Device Lot Number: A3H2602Y
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/07/2025
• Date Device Manufactured: 08/29/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female