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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD PTFE POLYMER PLEDGETS; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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DAVIS & GECK CARIBE LTD PTFE POLYMER PLEDGETS; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Back to Search Results
Model Number 88868678-01
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Inflammation (1932)
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 survey performed which covers the last 12 months for the adverse event reaction using the suture, one separation from suture material after vascular suture, and one mild acute inflammatory reaction were experienced.
 
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Brand Name
PTFE POLYMER PLEDGETS
Common Device Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key8897265
Report Number9612501-2019-01571
Device Sequence Number289788
Product Code DXZ
UDI-Device Identifier10884521103177
UDI-Public10884521103177
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K953289
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/15/2019
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 Model Number88868678-01
Device Catalogue Number88868678-01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2019
Initial Report FDA Received Date08/15/2019
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;
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