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

Model Number SL-693

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Anxiety (2328)

Event Date 02/15/2024

Event Type  malfunction  

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 Description

According to the reporter, during the suturing of the episiotomy, when suturing the subcutaneous tissue it was found that the needle was too thin, the arc length was 2mm short, and the suture was too thick and too hard.During a postpartum visit, the patient complained of slight pain the wound, was anxious, that the wound would not grow well.The physical examination revealed that the suture knot was not absorbed, and after investigation, it took 14 days for the suture to be hydrolyzed and absorbed.The patient's wound recovery was tracked, continued to observe, guided pregnant women to eat more high-protein foods, and kept the wound clean and dry.

• Brand Name: POLYSORB
• Type of Device: 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: 18980501
• MDR Text Key: 338761168
• Report Number: 1219930-2024-01335
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10884521049246
• UDI-Public: 10884521049246
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K963253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-693
• Device Catalogue Number: SL-693
• Device Lot Number: A2H0696FY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female