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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 12IN 4-0 S/A M-2; SUTURE, ABSORBABLE, NATURAL
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ETHICON INC. GUT CHR UD 12IN 4-0 S/A M-2; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Catalog Number 752G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 or Problem Description
It was reported that patient underwent a dental procedure on unknown date in (b)(6) 2018 and suture was used.The suture snapped during use.The surgeon used a different type of suture to complete the procedure.There were no patient consequences reported.
 
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Brand Name
GUT CHR UD 12IN 4-0 S/A M-2
Common Device Name
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7470251
Report Number2210968-2018-72411
Device Sequence Number10806321
Product Code GAL
UDI-Device Identifier10705031009912
UDI-Public10705031009912
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/04/2018
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
Operator of Device Health Professional
Device Expiration Date12/31/2021
Device Catalogue Number752G
Device Lot NumberLAZ619
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/04/2018
Initial Report FDA Received Date04/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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