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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 3-0 D/A TE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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ETHICON INC. PRLNE BLU 4X30IN 3-0 D/A TE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE Back to Search Results
Model Number D9749
Medical Device Problem Code Material Frayed (1262)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/08/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the surgery, it was felt that the suture had been frayed, so usage was stopped.There were no adverse consequences to the patient.
 
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Brand Name
PRLNE BLU 4X30IN 3-0 D/A TE
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10136584
Report Number2210968-2020-04472
Device Sequence Number2420937
Product Code GAW
UDI-Device Identifier10705031034587
UDI-Public10705031034587
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133356
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) 06/02/2020
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 NumberD9749
Device Catalogue NumberD9749
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/02/2020
Initial Report FDA Received Date06/10/2020
Patient Sequence Number1
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