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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD PLAIN GUT; SUTURE, ABSORBABLE, NATURAL
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DAVIS & GECK CARIBE LTD PLAIN GUT; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Model Number SG-5686
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443); No Code Available (3191)
Date of Event 10/09/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, post operatively on a face lift procedure, the suture did not absorb as expected that caused redness and swelling with puss.The patient had to return to the hospital and needed to be treated with antibiotics and some were given hydrocortisone cream to help.
 
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Brand Name
PLAIN GUT
Common Device Name
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key10767204
Report Number9612501-2020-01578
Device Sequence Number3318163
Product Code GAL
UDI-Device Identifier10884521055759
UDI-Public10884521055759
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K885018
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/31/2020
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 NumberSG-5686
Device Catalogue NumberSG-5686
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2020
Initial Report FDA Received Date10/31/2020
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 Hospitalization; Required Intervention;
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