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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number 88863090-61
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abscess (1690); Fistula (1862); Tissue Damage (2104); No Code Available (3191)
Date of Event 05/01/2018
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, two patients had deep suture abscesses that had produced chronic fistulas following a deep inferior epigastric perforator flap within weeks of surgery.The wounds have been drained for a year, even though they had wound care and been excised.Both patients had infections and inflamed granulation tissue around the sutures.It was stated that the deep knots of the suture were the source and they had two additional surgeries.The event resulted to unanticipated tissue loss and permanent tissue damage.
 
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Brand Name
TI-CRON
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 18750
DO  18750
MDR Report Key9760239
Report Number9612501-2020-00347
Device Sequence Number2787621
Product Code GAT
UDI-Device Identifier10884521059924
UDI-Public10884521059924
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K930591
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) 02/26/2020
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 Model Number88863090-61
Device Catalogue Number88863090-61
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2020
Initial Report FDA Received Date02/26/2020
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;
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