MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM0033
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during skin closure following an open mastectomy.The loop broke as the suture was pulled tight.A new suture was used to complete the procedure with no issues.The patient status is alive with no injury.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott ave; north haven CT 06473
• MDR Report Key: 6736386
• Report Number: 1219930-2017-06050
• Device Sequence Number: 13969337
• Product Code: GAM
• UDI-Device Identifier: 10884521131712
• UDI-Public: 10884521131712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: VLOCM0033
• Device Catalogue Number: VLOCM0033
• Device Lot Number: A7D0747VFX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR