MAUDE Adverse Event Report: RESORBA MEDICAL GMBH GLYCOLON; A STERILE, ABSORBABLE, SYNTHETIC SUTURE MATERIAL

Catalog Number PB41420

Device Problem Improper Chemical Reaction (2952)

Patient Problem Abrasion (1689)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

As the device is registered in the usa it has been reported despite the event occurring in germany.The event is still under investigation at this time.

Event Description

The following initial statement was provided by the user "after an extensive test phase in my practice, i found that the stitches do not dissolve.Even after three weeks, the stitches are still in situ and cause considerable discomfort to patients.When the sutures are removed, they are still absolutely stable and firm, with no signs of resorption, even though the tensile strength should decrease to 30% after 7 days." the device is expected to have under 6% tensile strength after 14 days, hence the user claims a device malfunction finding no fall in tensile strength as expected.

• Brand Name: GLYCOLON
• Type of Device: A STERILE, ABSORBABLE, SYNTHETIC SUTURE MATERIAL
• Manufacturer (Section D): RESORBA MEDICAL GMBH; 16 am flachmoor; nürnburg, 90475 ; GM 90475
• Manufacturer Contact: james o'crowley ; 16 am flachmoor; nürnburg, 90475 ; GM 90475
• MDR Report Key: 18942616
• MDR Text Key: 339222534
• Report Number: 9611459-2024-00003
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PB41420
• Device Lot Number: R00101764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• 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 Outcome(s): Other