MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 3013SP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional information was requested, and the following was obtained: what is the procedure name? =>no further information is available.What is the procedure date? =>no further information is available.What date did the reaction occur on? =>no further information is available.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.=>no further information is available.What is the most current patient status? =>no further information is available.Can you identify the lot number of the product that was used? =>no further information is available.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? =>no further information is available.What are were the diagnosis and indication for the index surgical procedure? =>no.Further information is available.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.=>no further information is available.Was there any intraoperative concurrent use of other products? =>no further information is available.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? =>no further information is available.Where was the surgicel used (on what tissue)? =>no further information is available.How much surgicel was used during the procedure? =>no further information is available.Was the surgicel product left in place? was the excess irrigated and removed? =>no further information is available.What were current symptoms following the index surgical procedure? onset date? =>no further information is available.Were cultures performed? if yes, what were the results? =>no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? =>no further information is available.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection? =>no further information is available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.After the procedure a post-operative infection occurred.Additional information was requested.

• Brand Name: SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10952310
• MDR Text Key: 219896393
• Report Number: 2210968-2020-09592
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 3013SP
• Device Catalogue Number: 3013SP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention