BIOSYN CM-879

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for BIOSYN CM-879 manufactured by Covidien Lp Llc North Haven.

Event Text Entries

[185197306] (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185197307] According to the reporter post-operative the spleen tumor removal in a veterinary procedure, the sutures used to close the wound came loose. Another operation was needed to close the wound of the animal. The surgical time was extended by more than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219930-2020-01348
MDR Report Key9887148
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN LP LLC NORTH HAVEN
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOSYN
Generic NameSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Product CodeGAM
Date Received2020-03-26
Model NumberCM-879
Catalog NumberCM-879
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP LLC NORTH HAVEN
Manufacturer Address195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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