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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 SL-5680
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Codes Injury (2348); Post Operative Wound Infection (2446)
Date of Event 03/23/2018
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, postoperatively, the surgeon had taken out 2 or 3 knots on the patient in 2-4 weeks after surgery.The patient was 3 months out and spitting suture again.The surgeon had 2 patients that had to go to the operating room to wash out their wound around multiple stitch abscesses in the last 3 months.To resolve the issue suture removal and wash out was required.
 
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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 Key7413536
Report Number9612501-2018-00716
Device Sequence Number1483002
Product Code GAM
UDI-Device Identifier10884521124622
UDI-Public10884521124622
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K963253
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 04/10/2018
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 NumberSL-5680
Device Catalogue NumberSL-5680
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2018
Initial Report FDA Received Date04/10/2018
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 Required Intervention;
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