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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 5-0 S/A PS-5 PRM; SUTURE, ABSORBABLE, NATURAL
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ETHICON INC. GUT CHR UD 18IN 5-0 S/A PS-5 PRM; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Catalog Number 1652G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the lot #.
 
Event or Problem Description
It was reported that a patient underwent a dental procedure on (b)(6) 2018 and suture was used.The needle broke during the procedure.Unknown as to how the procedure was completed.There were no adverse consequences for the patient.
 
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Brand Name
GUT CHR UD 18IN 5-0 S/A PS-5 PRM
Common Device Name
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7829823
Report Number2210968-2018-75532
Device Sequence Number11084516
Product Code GAL
UDI-Device Identifier10705031001602
UDI-Public10705031001602
Combination Product (Y/N)N
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/02/2018
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 Number1652G
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/02/2018
Initial Report FDA Received Date08/29/2018
Patient Sequence Number1
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