MAUDE Adverse Event Report: ETHICON, INC. VICRYL; SUTURE

Model Number J417

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

The suture needle broke and we retrieved the tip from the patient wound.

• Brand Name: VICRYL
• Type of Device: SUTURE
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 4924410
• MDR Text Key: 6054192
• Report Number: 4924410
• Device Sequence Number: 1
• Product Code: GAM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: J417
• Device Lot Number: HH2304
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 28 YR
• Patient Weight: 57