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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-1964
Medical Device Problem Codes Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during an ankle fussion procedure, while suturing the skin, it was reported that the suture broke and the needle bent.A new device was used to complete the case.No injury.
 
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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 Key8119848
Report Number9612501-2018-02144
Device Sequence Number18889338
Product Code GAR
UDI-Device Identifier10884521077782
UDI-Public10884521077782
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 company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2023
Device Model NumberSN-1964
Device Catalogue NumberSN-1964
Device Lot NumberD8E0698X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2018
Initial Report FDA Received Date11/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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