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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number 8886605731
Medical Device Problem Codes Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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, during a hand tendon repair, while suturing a tendon of the index finger, the thread came out the needle on the first stitch and broke.Four threads were used, with the same result every time.They used another strand to complete the case.There was no patient injury.
 
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Brand Name
MAXON
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key8727311
Report Number9612501-2019-01230
Device Sequence Number16609293
Product Code GAM
UDI-Device Identifier10884523001914
UDI-Public10884523001914
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K990951
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 06/24/2019
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 Date04/30/2023
Device Model Number8886605731
Device Catalogue Number8886605731
Device Lot NumberD8D2459X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2019
Initial Report FDA Received Date06/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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