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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 C427
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
It was reported that a patient underwent a colectomy procedure on (b)(6) 2016 and suture was used.The needle bent during the procedure.There was no adverse consequence to the patient.
 
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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.-JUAREZ
avenida de las torres 7125, co
l salvacar
ciudad juarez 32604
MX   32604
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5498582
MDR Text Key40257999
Report Number2210968-2016-06242
Device Sequence Number1
Product Code GAN
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 02/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC427
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
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