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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON 18IN 4-0 BLK S/A PS-1 PRM MP; SUTURE, NONABSORBABLE

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ETHICON INC. ETHILON 18IN 4-0 BLK S/A PS-1 PRM MP; SUTURE, NONABSORBABLE Back to Search Results
Catalog Number EH7957BH
Device Problem Component Incompatible (1108)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Attempts have been made to retrieve the device.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.Only pictures were received for analysis.Upon visual inspection of the pictures, a sample of product code eh7957b with description of 45 cm of length could be observed.However, no conclusion could be reach on the length of the suture as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Do you know if the customer has any unopened representative samples to return for evaluation? please explain is the problem relating to the labeling or is the problem relating to the length of the suture? is the issue related to incorrect product in the package?.
 
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, it was noted that the packaging shows 45 cm, but the suture inside the package was 75 cm long.There were no adverse patient consequences.Additional information has been requested.
 
Manufacturer Narrative
Product complaint #: (b)(4).Additional information was requested and the following was obtained: please explain is the problem relating to the labeling or is the problem relating to the length of the suture? according to customer suture length found inside the foil is 75 cm.According to label suture with 45 cm length should be inside.Is the issue related to incorrect product in the package? wrong product is inside the packages.Only pictures were received for analysis.Upon visual inspection of the pictures, a sample of product code eh7957b with description of 45 cm of length could be observed.However, no conclusion could be reach on the length of the suture as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Retain sample evaluation: from photo evaluation for the retain sample for product code eh7957bh55, lot # mlq481 it is notice that suture has three (3) as required for a 45cm long suture.Per fg retain sample evaluation it is the lot mlq481 was manufactured as per specification for a 45cm length suture.
 
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Brand Name
ETHILON 18IN 4-0 BLK S/A PS-1 PRM MP
Type of Device
SUTURE, NONABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key9117545
MDR Text Key195564309
Report Number2210968-2019-88083
Device Sequence Number1
Product Code GAR
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 08/30/2019
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
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Catalogue NumberEH7957BH
Device Lot NumberMLQ481
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/30/2019
Initial Date FDA Received09/25/2019
Supplement Dates Manufacturer Received09/26/2019
Supplement Dates FDA Received10/25/2019
Patient Sequence Number1
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