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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEMETECH, INC. DEMEGUY; SURGICAL SUTURE

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DEMETECH, INC. DEMEGUY; SURGICAL SUTURE Back to Search Results
Model Number DT-636-1(CC223019F4P)
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 08/04/2016
Event Type  malfunction  
Manufacturer Narrative
A complete review of the dhr record for the finished product was conducted.Demegut size 3-0, product code cc123019f4p, lot number ww152-15 was packaged on february 11, 2016 and product code dt-636-1 (cc223019f4p), lot number ww241-15 and the review of the dhrs did not indicate any issues during the manufacturing and packaging processes.All in-process tests met their respective specifications and, in addition, the in-process and final product inspections met the acceptance criteria.The review indicated that the product was made to meet standard product specifications with no changes/ modifications to the standard manufacturing process.A review of the packaging aql (acceptance quality limits) inspections that were performed during the packaging of the product was conducted.Demetech used an aql procedure based on ansi tables.The quality personnel did not find any defects.Based on our review of the samples' tensile strength, the data at the time of product release and retained testing data, the tensile strength and needle pull met all of the usp requirements for the lots corresponding suture size requirements.Demetech did not receive any samples for lot number ww152-15 and ww241-15.This investigation concluded that the quality, strength, or integrity of the product was not affected.
 
Event Description
On (b)(6) 2016, (b)(6) notified demetech corp that two separate doctors complaining about the same two issues.The first was the threads were breaking and the second was the needle was coming off the threads for the following lot numbers ww152-16 and ww241-15, product codes cc123019f4p & dt-636-1(cc223019f4p).
 
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Brand Name
DEMEGUY
Type of Device
SURGICAL SUTURE
Manufacturer (Section D)
DEMETECH, INC.
14175 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
DEMETECH, INC.
14175 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
linda hernandez
14175 nw 60 avenue
miami lakes, FL 33014
3058241048
MDR Report Key6083534
MDR Text Key59566482
Report Number3003063934-2016-00002
Device Sequence Number1
Product Code GAL
Combination Product (y/n)N
PMA/PMN Number
K072930
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date 10/27/2016
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? No
Device Operator No Information
Device Expiration Date11/30/2020
Device Model NumberDT-636-1(CC223019F4P)
Device Lot NumberWW241-15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2016
Initial Date FDA Received11/07/2016
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age15 YR
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