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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 N-2770-K
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2020
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 an open procedure, the thread broke easily. The suture was also reported to be thin and fragile. Another suture was used to resolve the issue. There is 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 Key9901752
MDR Text Key185762707
Report Number9612501-2020-00555
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK900531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN-2770-K
Device Catalogue NumberN-2770-K
Device LOT NumberD9F1135Y
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/17/2019
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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