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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD STEEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
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DAVIS & GECK CARIBE LTD STEEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE Back to Search Results
Model Number 88862222-69
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Code Tissue Damage (2104)
Date of Event 12/23/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, when the sternum was closed during a myocardial revascularization, three sutures dislodged.There was tissue damage as a result of this problem.
 
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Brand Name
STEEL
Common Device Name
SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key9590661
Report Number9612501-2020-00108
Device Sequence Number13582312
Product Code GAQ
UDI-Device Identifier10884521102330
UDI-Public10884521102330
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K955723
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/15/2020
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 Date12/31/2023
Device Model Number88862222-69
Device Catalogue Number88862222-69
Device Lot NumberD9A0987Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2020
Initial Report FDA Received Date01/15/2020
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 Other;
Patient Age75 YR
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