MAUDE Adverse Event Report: ETHICON INC. SURGIFLO UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

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

Patient Problem Wound Dehiscence (1154)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and absorbable hemostat was used.During the unknown procedure, there was vaginal cuff dehiscence.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).F10 component code: g07002 - device not returned.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.1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? 2.What are the name and date of index surgical procedure? 3.What were the diagnosis and indication for the index surgical procedure? 4.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.5.Was there any intraoperative concurrent use of other products? 6.What are the product code and lot number? 7.What was the intended use of the surgiflo? 8.Where was the surgiflo used (on what tissue)? 9.How much surgiflo was used during the procedure? 10.Was the surgiflo product left in place? was the excess removed? 11.What were current symptoms following the index surgical procedure? onset date? 12.Has any surgical or medical intervention been performed? 13.What is physician¿s opinion as to the cause of or contributing factors to this event? 14.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative vaginal cuff dehiscence? 15.What is the patient¿s current status? 16.What is the users experience w/ surgiflo and other hemostatic agents? 17.Has this event previously been submitted to ethicon? if so, please provide the corresponding reference number.18.Is the complaint sample available to be returned for evaluation? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SURGIFLO UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 19138971
• MDR Text Key: 340561355
• Report Number: 2210968-2024-100011
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/11/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other