MAUDE Adverse Event Report: SURGIFLO NGEN LYO THROMBIN 2ML; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2994
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Swelling/ Edema (4577)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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: the surgeon confirmed on the call that the product was being used prophylactically and not to treat active bleeding.He also stated that the excess product was not removed.The following information was requested, but unavailable: what is the lot number? is this a male or female? what is the age of the patient? has the patient had previous spine surgery? on what date was the index surgery? what spine surgery did the patient undergo? on what type of bleeding was surgiflo hemostatic matrix kit with thrombin (product code 2994, abbreviated surgiflo 2994) used? do you have the lot number of the surgiflo 2994 being used? did the surgeon remove excess surgiflo 2994 when hemostasis had been achieved? or did the surgeon leave the full unit (8 ml) in the wound upon closing up? did the surgeon use any other hemostats during surgery? if yes, what brands were they? were they removed when hemostasis had been achieved? how was the immediate post-op period in pacu? please let us know if complications occurred.On what post-op day was the patient discharged home? on what post-op day did the patient present with a red and swollen neck?.Did the patient present with any other symptoms? on what post-op day was the re-surgery? what is the name of the procedure? what was the indication for using the product? can specific patient demographics initials / id; 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 of study drugs be provided? what is the surgeons opinion as to the relationship of the product to the symptoms? what is the current condition of the patient? is the surgeon a new user of surgiflo 2994? has the surgeon undergone product training in the use of surgiflo 2994? is this hospital a recent conversion account from floseal to surgiflo 2994?.
Event or Problem Description
It was reported that a patient underwent a spine procedure on an unknown date.A little over a week post operative the patient presented with a red and swollen neck.The patient was brought back to the operating room where the incision was reopened.There was zero blood and the surgeon found that the incision site was full of water and a mixture of the product.The water and product mixture were drained and the incision was sutured closed.The patient is doing fine.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/7/2021.Investigation summary = > no complaint sample was received.In conclusion, surgiflo® hemostatic matrix kit with thrombin is not for prophylactic use - the device is indicated for "surgiflo® hemostatic matrix, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical".Excess surgiflo® hemostatic matrix should be removed once hemostasis has been achieved, because of the possibility of dislodgment of the device or compression of other nearby anatomic structures.Only the minimum amount of surgiflo® hemostatic matrix needed to achieve hemostasis should be used.Once hemostasis is achieved, any excess surgiflo® hemostatic matrix should be carefully removed.The use of surgiflo® hemostatic matrix kit with thrombin product code 2994 in this event is evaluated to be off-label.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 NGEN LYO THROMBIN 2ML
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• MDR Report Key: 11662288
• Report Number: 2210968-2021-70009
• Device Sequence Number: 2545746
• Product Code: LMF
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021
• Report Date (Section F): 04/13/2021

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: 2994
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/17/2021
• Date Report to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention