CHROMIC GUT SG-5644G

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 2020-02-14 for CHROMIC GUT SG-5644G manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[179756112] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[179756113] According to the reporter, during an open septoplasty, while using running suturing technique, the needle came off from suture before it was tied. Another suture was used to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612501-2020-00273
MDR Report Key9712114
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-14
Date of Report2020-03-25
Date Mfgr Received2020-03-09
Device Manufacturer Date2015-10-23
Date Added to Maude2020-02-14
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 0101
Manufacturer CountryDO
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHROMIC GUT
Generic NameSUTURE, ABSORBABLE, NATURAL
Product CodeGAL
Date Received2020-02-14
Returned To Mfg2020-02-24
Model NumberSG-5644G
Catalog NumberSG-5644G
Lot NumberD5K1882X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-14

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