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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 VLOCL0014
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 09/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, both needle and thread broke during a procedure, they remained for a few moments in the abdominal wall of the patient, looking and trying to recover the needle.However, it remained stuck in the patient's abdominal wall.
 
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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 Key8013788
Report Number1219930-2018-05681
Device Sequence Number16489400
Product Code GAM
UDI-Device Identifier10884521130371
UDI-Public10884521130371
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K091087
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/29/2018
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 Date05/31/2021
Device Model NumberVLOCL0014
Device Catalogue NumberVLOCL0014
Device Lot NumberA8E0728VX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/02/2018
Initial Report FDA Received Date10/29/2018
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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