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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
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COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC Back to Search Results
Model Number VLOCM0625
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 05/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
According to the reporter, during suturing of the pectoralis major, the thread breaks occurred.Another suture was used to resolve the issue.There was no patient injury.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
V-LOC 90
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key13306496
Report Number1219930-2022-00231
Device Sequence Number4965285
Product Code GAM
UDI-Device Identifier10884521132634
UDI-Public10884521132634
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K100257
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/20/2022
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 Date04/30/2023
Device Model NumberVLOCM0625
Device Catalogue NumberVLOCM0625
Device Lot NumberA0E0307VY
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/04/2022
Initial Report FDA Received Date01/20/2022
Date Device Manufactured05/10/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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