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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number UL-204
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/18/2019
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 open procedure on fractured forearm, the suture start to untie while cleaning the skin after su turing.They removed the suture and used another suture to resolve the issue.There was no patient injury.
 
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Brand Name
POLYSORB
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key8500627
Report Number9612501-2019-00755
Device Sequence Number11452770
Product Code GAM
UDI-Device Identifier20884521049465
UDI-Public20884521049465
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K963253
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) 04/10/2019
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 Date05/31/2022
Device Model NumberUL-204
Device Catalogue NumberUL-204
Device Lot NumberD7E0391X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/19/2019
Initial Report FDA Received Date04/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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