Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC Back to Search Results
Model Number 6124-21
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
Date of Event 05/27/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during anastomosis of ureter, the suture broke.2 additional sutures had to be used to resolve the issue in order to complete the case.This resulted to increased manipulation and trauma to ureter.Anesthesia time was extended by one hour.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAXON
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DR  0101
MDR Report Key12222989
Report Number9612501-2021-01224
Device Sequence Number17104330
Product Code GAM
UDI-Device Identifier10884523002072
UDI-Public10884523002072
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K990951
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 07/25/2021
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 Number6124-21
Device Catalogue Number6124-21
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/01/2021
Initial Report FDA Received Date07/25/2021
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;
-
-