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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD DERMALON SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

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DAVIS & GECK CARIBE LTD DERMALON SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Back to Search Results
Model Number 88861749-24
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during a septorhinoplasic procedure, on wound closure, just when the surgeon throw the suture through the tissue, the needle detached from the thread on the four devices. They used another suture to complete the case. There was no patient injury.

 
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Brand NameDERMALON
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO 0101
Manufacturer (Section G)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO 0101
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9914619
MDR Text Key186107369
Report Number9612501-2020-00584
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK981582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number88861749-24
Device Catalogue Number88861749-24
Device LOT NumberD9G1500FY
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/07/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/12/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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