MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 1X2; HEMOSTATIC AGENT, ABSORBABLE

Catalog Number	2081
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fever (1858); Vomiting (2144); Not Applicable (3189)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Vomitting.Surgical intervention.Vomiting occurred.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.What was the date of the initial procedure? what date did the patient experience fever and vomitting? did the patient have an infection prior to the initial procedure? if so, where? what are the patient's demographics - age, date of birth, bmi, past medical history? during the re-operation, what was performed? the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Event or Problem Description
It was reported that the patient underwent an endometriosis procedure on an unknown date, and absorbable hemostat was used.After discharge, the patient experienced fever and vomited.The physician opines that semi fluid seen in ultrasound may have led to the vomiting.The patient underwent a re-operation.The physician opines that the contributing factors to the reaction may be because of infection or use of other hemostat.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: please provide the date of the surgery and date of the event.(b)(6) 2017 , (b)(6) 2017.What date did the patient experience fever and vomiting? after discharge, patient was having high fever and vomit continuously.Patient is ok now.Did the patient have an infection prior to the initial procedure? if so, where? vaginal infection exist at time of surgery.No other medical history.During the re-operation, what was performed? no information.

• Brand Name: SURGICEL SNOW 1X2
• Common Device Name: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7216984
• Report Number: 2210968-2018-70435
• Device Sequence Number: 1044353
• Product Code: LMF
• UDI-Device Identifier: 10705031063587
• UDI-Public: 10705031063587
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 2081
• Device Lot Number: KJB8391
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR