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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, NATURAL
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ETHICON INC. GUT CHR UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Catalog Number 1637G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/14/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The following information was requested, but unavailable: please verify that 1 suture broke two times? also, the lot reported med862 is not valid.Please verify the lot.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 or Problem Description
It was reported a patient underwent an dental extraction procedure on (b)(6) 2018 where suture was used.The suture thread part broke in the middle twice while suturing.The pieces that broke were retrieved and patient.No adverse patient consequences.
 
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Brand Name
GUT CHR UD 18IN 4-0 S/A PS-2 PRM MP
Common Device Name
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7860581
Report Number2210968-2018-75745
Device Sequence Number1337391
Product Code GAL
UDI-Device Identifier10705031001503
UDI-Public10705031001503
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/14/2018
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 Catalogue Number1637G
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/14/2018
Initial Report FDA Received Date09/10/2018
Patient Sequence Number1
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