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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD NOVAFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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DAVIS & GECK CARIBE LTD NOVAFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number 8886441913
Medical Device Problem Codes Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/27/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the material end of the needle developed a hook which got stuck in the patients face and was unable to pass through.The hook was eventually released and remained intact but misshapen.The suture was being used to fine suture a face and was not being used on skin that would cause the needle to buckle.
 
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Brand Name
NOVAFIL
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DR  0101
MDR Report Key12301905
Report Number9612501-2021-01331
Device Sequence Number11679663
Product Code GAT
UDI-Device Identifier10884521099753
UDI-Public10884521099753
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K990952
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/10/2021
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
Operator of Device Health Professional
Device Expiration Date05/31/2025
Device Model Number8886441913
Device Catalogue Number8886441913
Device Lot NumberD0F1287Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2021
Initial Report FDA Received Date08/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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