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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number GMM-344L
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/21/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter: post- operatively 2.5 weeks ((b)(6)) after distal pancreas/ splenectomy /hiatal hernia procedure, the suture was observed as falling apart.It was being applied at anterior fascia.Two double loop running technique was used.In order to resolve the issue and complete the case, used another suture.Patient status: recovering w/ wound vac.Patient' s medical history: fibromyalgia, autoimmune disease.
 
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Brand Name
MAXON
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 Key6981124
Report Number9612501-2017-06498
Device Sequence Number16450849
Product Code GAM
UDI-Device Identifier20884523004783
UDI-Public20884523004783
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K990951
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2022
Device Model NumberGMM-344L
Device Catalogue NumberGMM-344L
Device Lot NumberD7E2104X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/21/2017
Initial Report FDA Received Date10/26/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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