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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number GMJ63M
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Codes Wound Dehiscence (1154); Tissue Damage (2104); No Code Available (3191)
Date of Event 01/24/2019
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, post - operative of tongue resection, dehiscence occurred due to thread loosening a few days after the procedure.Suturing was performed again to complete the case.Less than 200 cc of bleeding occurred as a result of the issue.
 
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Brand Name
BIOSYN
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 Key8378098
Report Number9612501-2019-00385
Device Sequence Number344714
Product Code GAM
UDI-Device Identifier00884521032883
UDI-Public00884521032883
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K000037
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/28/2019
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 NumberGMJ63M
Device Catalogue NumberGMJ63M
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2019
Initial Report FDA Received Date02/28/2019
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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