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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A TG140-8; SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHLN BLK 12IN 10-0 D/A TG140-8; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Model Number 7718G
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that a patient underwent an ophthalmic procedure on an unknown date; and a suture was used.During the procedure, a suture detached from the needle easily.It was not a control release needle.It was further reported that an extra suture was found in the package.There were no adverse patient consequences reported.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Date sent to the fda: 08/04/2020.A manufacturing record evaluation was performed for the finished device batch phr454, and no non-conformances were identified.Additional h3 investigation summary: one open winding former with a detached needle and a needle-suture piece of product code 7718, lot phr454 were received for analysis.During visual inspection of the detached needle, the closure of the channel could be observed as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.The needle-suture piece was examined, the insertion end was not noted; this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
ETHLN BLK 12IN 10-0 D/A TG140-8
Type of Device
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10238879
MDR Text Key197775749
Report Number2210968-2020-05087
Device Sequence Number1
Product Code GAR
UDI-Device Identifier10705031010529
UDI-Public10705031010529
Combination Product (y/n)N
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/25/2020
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 Date06/30/2024
Device Model Number7718G
Device Catalogue Number7718G
Device Lot NumberPHR454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Initial Date Manufacturer Received 06/25/2020
Initial Date FDA Received07/07/2020
Supplement Dates Manufacturer Received07/24/2020
Supplement Dates FDA Received08/04/2020
Patient Sequence Number1
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