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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 5-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MCRYL+ UD 18IN 5-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Model Number MCP490G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/05/2020
Type of Reportable Event Malfunction
Additional 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.The following information was requested, but was unavailable: please clarify how the procedure was complete.Please provide lot number.Please provide procedure name and date.Any patient consequences? status of product return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.Additional information was requested.
 
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Brand Name
MCRYL+ UD 18IN 5-0 S/A P-1 PRM
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10521162
Report Number2210968-2020-06806
Device Sequence Number3336625
Product Code GAM
UDI-Device Identifier10705031046542
UDI-Public10705031046542
Combination Product (Y/N)N
PMA/510(K) Number
K050845
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/31/2020
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 Model NumberMCP490G
Device Catalogue NumberMCP490G
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/31/2020
Initial Report FDA Received Date09/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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