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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-762
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/03/2017
Type of Reportable Event Serious Injury
Event or Problem Description
According to the reporter: during a procedure, suture thread broke while closing the wound.The event lead to or extend patient hospitalization.Another intervention was done to resolve the issue in order to complete the case.There will be an additional operation performed to correct the issue.The patient status is alive with no injury.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key6489534
Report Number9612501-2017-05340
Device Sequence Number556030
Product Code GAR
UDI-Device Identifier10884521080164
UDI-Public10884521080164
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K900531
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 03/14/2017
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? Yes
Operator of Device Health Professional
Device Expiration Date05/01/2019
Device Model NumberSN-762
Device Catalogue NumberSN-762
Device Lot NumberD4E0959X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/14/2017
Supplement Date Received by Manufacturer03/14/2017
Initial Report FDA Received Date04/13/2017
Supplement Report FDA Received Date10/03/2017
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; Required Intervention;
Patient Weight46
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