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U.S. Department of Health and Human Services

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

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DAVIS & GECK CARIBE LTD MONOSOF SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Back to Search Results
Model Number GNJ-283
Device Problems Break (1069); Product Quality Problem (1506); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, intraoperatively, the thread was transparent. Also, the thread broke easily while in use. While inserting with the needle, resistance was strong. The procedure was completed with another device. The surgical time was extended by less than 30 minutes. There was no patient injury.

 
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Brand NameMONOSOF
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 Key9530433
MDR Text Key181558062
Report Number9612501-2019-02542
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK900531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGNJ-283
Device Catalogue NumberGNJ-283
Device LOT NumberD9B463Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated By Manufacturer? Yes
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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