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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 8886626761
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/26/2017
Type of Reportable Event Malfunction
Event or Problem Description
According to the reporter, during the continuous suturing of the myometrium in laparoscopic uterine fibroids, both the need and thread were broken.During the process of clamping the tail and the doctor did the stapling, it reflect the same before the surgery.The device was just removed from the packaging.No harm was caused to the patient.
 
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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 Key6756711
Report Number9612501-2017-05874
Device Sequence Number2013778
Product Code GAM
UDI-Device Identifier20884523002666
UDI-Public20884523002666
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K990951
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2021
Device Model Number8886626761
Device Catalogue Number8886626761
Device Lot NumberD6J1510X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2017
Initial Report FDA Received Date08/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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