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 ACID
  • 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 ACID Back to Search Results
Model Number 8886628771
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/04/2019
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, following a caesarean section procedure, the suture thread broke in the middle.The patient went back to theatre to close the sheath again.This resulted to extended surgical time of more than 30 minutes and extended patient hospitalization of four days.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8829442
Report Number9612501-2019-01462
Device Sequence Number11434864
Product Code GAM
UDI-Device Identifier20884523002802
UDI-Public20884523002802
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K990951
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/25/2019
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 Expiration Date12/31/2021
Device Model Number8886628771
Device Catalogue Number8886628771
Device Lot NumberD6M0583X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/10/2019
Initial Report FDA Received Date07/25/2019
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 Hospitalization; Required Intervention;
-
-