PROLENE*BLUE 3-0 45CM (1)SC-24 8184T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PROLENE*BLUE 3-0 45CM (1)SC-24 8184T manufactured by Ethicon Inc..

Event Text Entries

[186695183] (b)(4). A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. The patient demographic info: age, gender, weight, bmi at the time of index procedure on what tissue what the suture used? What was the tissue condition, i. E. Normal or thin, calcified, fragile, diseased? What instruments were used to grasp the needle? Where was the needle grasped during use? Was the entire device removed from the patient on (b)(6) 2020? Does the piece/device remain retained in the patient? S tissue? If the pieces were retained, where is the device located/in what structure? Other relevant patient history/concomitant medications. Will the actual device be returned for evaluation? Will representative samples from the same lot be returned for evaluation? What is physician? S opinion as to the etiology of or contributing factors to this event?
Patient Sequence No: 1, Text Type: N, H10


[186695184] It was reported that the patient underwent a c-section procedure on (b)(6) 2020 and the suture was used for skin closure. While at the right angle of a surgical wound, there was a rupture/breakage of the needle in the proximal third. It was also reported that more than half the needle was retain in the patient. Exploration of the surgical wound was performed with soft tissue ultrasound and rx intraoperative abdomen without finding the needle. It was reported that the patient had to be re-operated on (b)(6) 2020 in order to extract the needle which was found in the subcutaneous tissue. The patient had to stay one more day in the hospital. The patient was well and released on (b)(6) 2020. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02500
MDR Report Key9908223
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-03
Date of Event2020-03-02
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-08-19
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-BRAZIL
Manufacturer StreetRODOVIA PRESIDENTE DUTRA KM 154
Manufacturer CitySAO PAOLO 12240
Manufacturer CountryBR
Manufacturer Postal Code12240
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROLENE*BLUE 3-0 45CM (1)SC-24
Generic NameSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Product CodeGAW
Date Received2020-03-31
Catalog Number8184T
Lot NumberAM5324
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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