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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number VLOCL0814
Medical Device Problem Codes Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/10/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
( reopening of incision ).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a laparoscopic inguinal hernia repair, the loop unraveled, there was a risk of infection due to reopening the incision which extended the surgical time.They used another device to complete the case.
 
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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 Key7891498
Report Number1219930-2018-05122
Device Sequence Number11221864
Product Code GAM
UDI-Device Identifier20884521131320
UDI-Public20884521131320
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K091087
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/19/2018
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 Expiration Date06/30/2020
Device Model NumberVLOCL0814
Device Catalogue NumberVLOCL0814
Device Lot NumberA7F0586VX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2018
Initial Report FDA Received Date09/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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