MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCL2825
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Seroma (2069); Urinary Tract Infection (2120)
Date of Event	01/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: abdominal mesh sacrocolpopexy without promontory fixation: initial results of the peritoneocolpopexy technique source: the journal of urology® vol.193, 2089-2094, accepted for publication january 7, 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, (january 2015) this study aimed to evaluate a new method of mesh fixation in open surgery for pelvic organ prolapse that included the use of v-loc.Three postoperative grade i complications (one seroma, two urinary tract infections, one case of cellulitis), and one incarcerated hernia (noted as small bowel obstruction) at 6 days postoperatively.However additional details were not included.Grade i complications were treated conservatively and the hernia was repaired without bowel resection or compromise of prolapse repair.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 10057937
• Report Number: 1219930-2020-02031
• Device Sequence Number: 2783000
• Product Code: GAM
• UDI-Device Identifier: 10884521215115
• UDI-Public: 10884521215115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: VLOCL2825
• Device Catalogue Number: VLOCL2825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR