MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 2081

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

Patient Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Skin Inflammation/ Irritation (4545)

Event Date 01/10/2024

Event Type  Injury  

Event Description

It was reported that a 50 year old patient underwent an unknown procedure on an unknown date where absorbable hemostat was used.After intraoperative hemostasis, the surgical wound was covered with, and a rapid increase in heart rate occurred, with a maximum of 155 beats per minute.Blood pressure dropped to 60/40, and the patient's arms and face were found to have papules and redness.It was suspected that the absorbable hemostat triggered an allergic reaction.Immediately, the absorbable hemostat material was removed through laparotomy and sterilized with water.After washing with water, the heart rate and blood pressure returned to normal.After surgery, the patient was sent to the icu for observation.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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 is the lot number? 7.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 8.Where was the surgicel used (on what tissue)? 9.How much surgicel was used during the procedure? 10.Was the surgicel product left in place? was the excess removed? 11.What were current symptoms following the index surgical procedure? onset date? 12.Did the patient undergo a patch test? 13.Has any surgical or medical intervention been performed? 14.What is physician¿s opinion as to the cause of or contributing factors to this event? 15.Was there an alleged deficiency of the surgicel that contributed to the patient¿s rapid increase of heart rate? 16.What is the patient¿s current status? 17.What is the users experience w/ surgicel original and other hemostatic agents? 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.

Manufacturer Narrative

Product complaint # (b)(4) additional information was requested, and the following was obtained: 1.What are the name and date of index surgical procedure? the procedure name is unk, date is january 10, 2024.2.What is the lot number? spes5891 3.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? address active bleeding 4.What were current symptoms following the index surgical procedure? onset date? after intraoperative hemostasis, the surgical wound was covered with surgicel (2081), after which the heart rate increased rapidly, with the maximum heart rate of 155 beats/min, and the blood pressure decreased to 60/40.The patient was found to have maculopapule and redness on the arms and face, which was suspected to be allergic to hemostatic materials.The patient was immediately given laparotomy to remove the hemostatic materials and washed with large amount of sterile water, after which the heart rate and blood pressure returned to normal state.The patient was sent to icu for observation after operation.5.Has any surgical or medical intervention been performed? the patient was immediately given laparotomy to remove the hemostatic materials and washed with large amount of sterile water, after which the heart rate and blood pressure returned to normal state.The patient was sent to icu for observation after operation.6.What is physician¿s opinion as to the cause of or contributing factors to this event? surgicel (2081) the following information was requested, but unavailable: 1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? 2.What were the diagnosis and indication for the index surgical procedure? 3.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.4.Was there any intraoperative concurrent use of other products? 5.Where was the surgicel used (on what tissue)? 6.How much surgicel was used during the procedure? 7.Was the surgicel product left in place? was the excess removed? 8.Did the patient undergo a patch test? 9.Was there an alleged deficiency of the surgicel that contributed to the patient¿s rapid increase of heart rate? 10.What is the patient¿s current status? 11.What is the users experience w/ surgicel original and other hemostatic agents? 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: SURGICEL SNOW 1INX2IN(2.5CMX5.1CM)
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18539744
• MDR Text Key: 333180255
• Report Number: 2210968-2024-00509
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031063587
• UDI-Public: 10705031063587
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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
• Device Catalogue Number: 2081
• Device Lot Number: SPES5891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 01/29/2024
• Supplement Dates FDA Received: 01/22/2024; 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention