SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

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 2020-03-10 for SURGICEL ABSORBABLE HEMOSTAT UNKNOWN manufactured by Ethicon Inc..

Event Text Entries

[186295228] Product complaint # (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. 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? Date and name of index surgical procedure? The diagnosis and indication for the index surgical procedure? Relevant patient history? Any concurrent use of other products? Product code and lot #? What was the intended use of the surgicel? Where was the surgicel used (on what tissue)? How much surgicel was used during the procedure? Was the surgicel product left in place? Was the excess irrigated and removed? What were current symptoms following the index surgical procedure? Onset date? Were cultures performed? If yes, results? Has any surgical or medical intervention been performed? What is physician? S opinion as to the etiology of or contributing factors to this event? Was there an alleged deficiency of the surgicel that contributed to the patient? S post-operative infection? What is the patient? S current status? Will product be returned, return date, tracking information?
Patient Sequence No: 1, Text Type: N, H10


[186295229] It was reported that a patient underwent a total hysterectomy and an absorbable hemostat was used. Post operatively an infection occured. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-01917
MDR Report Key9815074
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-02-11
Date of Event2020-01-01
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-10
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.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICEL ABSORBABLE HEMOSTAT UNKNOWN
Generic NameAGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
Product CodeLMG
Date Received2020-03-10
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 2020-03-10

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