MAUDE Adverse Event Report: ETHICON INC. SURGICEL NU KNIT HEMO 15X23; HEMOSTATIC AGENT, ABSORBABLE

Catalog Number	1946
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
((b)(4).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.When did the healthcare provider discover the material coming through the drain? the initial procedure was on (b)(6) 2017.What date was the second procedure? where exactly was the drain placed? what are the patient demographics ¿ age, gender, date of birth, past medical history? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent a bowel surgery and absorbable hemostat was used.It was reported that just after a surgery, reoperation was performed because the drainage seemed like feces flowed through the drain.The surgeon confirmed it was not feces but piece of the absorbable hemostat.Additional information has been requested.
Additional Manufacturer Narrative
Pc-000092649 additional information was requested and the following was obtained: when did the healthcare provider discover the material coming through the drain? => on (b)(6) 2017.The initial procedure was on (b)(6) 2017.What date was the second procedure? =>no information.Where exactly was the drain placed? =>no information.What are the patient demographics ? => no information.Age, gender, date of birth, past medical history? => no information.What is the patient¿s current status? => no information.

• Brand Name: SURGICEL NU KNIT HEMO 15X23
• Common Device Name: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7183180
• Report Number: 2210968-2018-70225
• Device Sequence Number: 1044255
• Product Code: LMF
• UDI-Device Identifier: 10705031002999
• UDI-Public: 10705031002999
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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 Catalogue Number: 1946
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1