BIOSYN SM-5678

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for BIOSYN SM-5678 manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[185494486] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185494487] According to the reporter during total hysterectomy procedure, while using running stitch to close the skin, the suture popped off the needle. This happened twice. A third suture was opened and used with no issues. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612501-2020-00538
MDR Report Key9896533
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-05-29
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 G1DAVIS & GECK CARIBE LTD
Manufacturer StreetZONA FRANCA DE SAN ISIDRO
Manufacturer CitySANTO DOMINGO 18750
Manufacturer CountryDO
Manufacturer Postal Code18750
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOSYN
Generic NameSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Product CodeGAM
Date Received2020-03-30
Model NumberSM-5678
Catalog NumberSM-5678
Lot NumberD9E3294FY
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 18750 DO 18750


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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