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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 88861741-21
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2016
Event Type  malfunction  
Event Description
According to the reporter, pre-operatively, as soon as the suture was opened, the thread was detached form the needle.No patient involved.
 
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Brand Name
DERMALON
Type of Device
SUTURE, 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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6855874
MDR Text Key85743256
Report Number9612501-2017-06112
Device Sequence Number1
Product Code GAR
UDI-Device Identifier20884521070711
UDI-Public20884521070711
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K981582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model Number88861741-21
Device Catalogue Number88861741-21
Device Lot NumberD6D2860X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2017
Initial Date FDA Received09/11/2017
Date Device Manufactured04/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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