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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MONOCRYL (POLIGLECAPRONE 25) SUTURE; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MONOCRYL (POLIGLECAPRONE 25) SUTURE; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number Y489G
Device Problem Detachment Of Device Component (1104)
Patient Problems Anxiety (2328); Reaction (2414); No Code Available (3191)
Event Date 01/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported that the patient underwent an eyebrow procedure that while suturing the eyebrow on (b)(6) 2016.The needle detached from the suture as it was being pulled through the second skin flap.While putting a new needle in the needle holder, the previous needle slipped in the sutured wound and it was not possible to find it by examination.Two days later a cat was performed on the patient's face and the wound was re-opened and the needle was extracted.There were no clinical consequences to the patient once the needle was removed.
 
Manufacturer Narrative
(b)(4).The one actual sample was visually examined and found to have a damage at the needle barrel and suture remnant with broke off appearance was found in barrel.The loose detached needle with a damage at the needle barrel due to swaging process.
 
Manufacturer Narrative
(b)(4).Date sent to the fda: 12/19/2018.It was reported by the attorney that after the surgery for the removal of the needle, the patient suffered from an allergic reaction and an adjustment disorder with anxious symptoms.Hospital: (b)(6).
 
Manufacturer Narrative
(b)(4).Date sent to the fda: 06/12/2019.It was reported by the attorney that the patient underwent 2 procedures on (b)(6) 2016 for surgical exploration and the removal of the needle.Patient dob (b)(6) 2012.
 
Manufacturer Narrative
(b)(4).Date sent to the fda: 06/12/2019.It was reported by the attorney that the patient underwent 2 procedures on (b)(6) 2016 for surgical exploration and the removal of the needle.Patient dob (b)(6) 2012.
 
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Brand Name
MONOCRYL (POLIGLECAPRONE 25) SUTURE
Type of Device
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-UK
simpson parkway, kirkton campu
s
livingston
UK  
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5461383
MDR Text Key39058921
Report Number2210968-2016-05464
Device Sequence Number1
Product Code GAN
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K964072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Catalogue NumberY489G
Device Lot NumberHC5GPHN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/03/2016
Initial Date FDA Received02/25/2016
Supplement Dates Manufacturer ReceivedNot provided
12/13/2018
06/03/2019
06/03/2019
Supplement Dates FDA Received03/29/2016
12/19/2018
06/12/2019
06/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age3 YR
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