VICRYL POLYGLACTIN 910 SUTURE FRJV459

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 2020-03-26 for VICRYL POLYGLACTIN 910 SUTURE FRJV459 manufactured by Ethicon Inc..

Event Text Entries

[186686107] (b)(4). Additional information was requested and the following was obtained: was medication prescribed for the superficial site infection? If yes, please describe. Antibiotics were prescribed. Cannot remember the name of the medicine. Date and name of index surgical procedure - cannot associate a procedure name to a specific complaint. For these 4 complaints, it can be a ptosis cure, a breast implant or a thigh lifting. On what tissue was the suture used? The device was used on skin and subcutaneous tissue. What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? The tissue was normal. What were current symptoms following the index surgical procedure? Onset date? The healing was normal during the 3 first weeks, the infection occurred after then. Were cultures performed? If yes, results? Did not know if culture was performed. What is the patient? S current status? The patients go well. 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. The patient demographic info: age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? Were there any changes to cleansing regimens preoperatively? What were current symptoms following the index surgical procedure? Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? Did the patient receive any prophylactic antibiotics pre-, intra-op? Did the patient receive oral or topical antibiotics? Were cultures performed? Results? Other relevant patient history/concomitant medications. Please clarify lot number mmbdrjo as it is not a valid lot. If applicable, will product be returned, return date, tracking information what is physician? S opinion as to the etiology of or contributing factors to this event? What is the patient? S status? Note: events reported via mw 2210968-2020-02385, 2210968-2020-02387, 2210968-2020-02389.
Patient Sequence No: 1, Text Type: N, H10


[186686108] It was reported that the patient underwent an unknown procedure on an unknown date and suture was used. The procedure was reported to be ptosis cure, breast implant or thigh lift and device was used on skin and subcutaneous tissues. The patient healing was normal during the first three weeks post-op. The patient experienced a superficial infection and delay in healing three weeks post-op and was treated by antibiotic therapy. The patient is reported as well. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02386
MDR Report Key9885395
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-13
Date of Event2020-01-06
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-26
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.-GMBH
Manufacturer StreetROBERT-KOCH STRASSE 1
Manufacturer CityNORDERSTEDT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVICRYL POLYGLACTIN 910 SUTURE
Generic NameSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Product CodeGAM
Date Received2020-03-26
Catalog NumberFRJV459
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 2020-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.