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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 G-1774-K
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/26/2019
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, ten day post-ophthalmic surgery, patient was seen by surgeon and stated that the suture did not dissolved in the expected amount of time.Reoperation was done to resolve the issue and noted that the suture was difficult to removed from the patient.
 
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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 Key9347111
Report Number9612501-2019-02239
Device Sequence Number2269233
Product Code GAL
UDI-Device Identifier10884521054400
UDI-Public10884521054400
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K885018
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/20/2019
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 NumberG-1774-K
Device Catalogue NumberG-1774-K
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/04/2019
Initial Report FDA Received Date11/20/2019
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 Required Intervention;
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