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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
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DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Back to Search Results
Model Number SN-5666
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Local Reaction (2035); Swelling (2091)
Type of Reportable Event Serious Injury
Event or Problem Description
According to the reporter, there was redness and swelling at the suture site.The suture had to be removed and replaced.There was no medical attention or hospitalization required.The wound healed successfully.
 
Additional Manufacturer Narrative
The aware date was submitted incorrectly on the initial report.The aware date for this mdr is (b)(6) 2017.
 
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Brand Name
MONOSOF
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key6449452
Report Number9612501-2017-05226
Device Sequence Number11107190
Product Code GAR
UDI-Device Identifier10884521078765
UDI-Public10884521078765
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K900531
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/07/2017
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? No
Operator of Device Health Professional
Device Expiration Date04/30/2021
Device Model NumberSN-5666
Device Catalogue NumberSN-5666
Device Lot NumberD6D1967X
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 02/07/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date03/31/2017
Supplement Report FDA Received Date04/04/2017
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 Hospitalization; Other;
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