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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. CATGUT CHROMIC4-0 70CM (1)SH-1; SUTURE, ABSORBABLE, NATURAL
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ETHICON INC. CATGUT CHROMIC4-0 70CM (1)SH-1; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Catalog Number G181T
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
It was reported that a patient underwent a surgical procedure on (b)(6) 2018 and suture was used.During the procedure, the suture released from the needle.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
CATGUT CHROMIC4-0 70CM (1)SH-1
Type of Device
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7312861
MDR Text Key101522067
Report Number2210968-2018-71266
Device Sequence Number1
Product Code GAL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K946173
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 02/16/2018
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 Catalogue NumberG181T
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/16/2018
Initial Date FDA Received03/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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