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

Model Number	2081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? date and name of index surgical procedure? lot #? what were current symptoms following the index surgical procedure? onset date? has any surgical or medical intervention been performed? what is physician¿s opinion as to the etiology of or contributing factors to this event? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative allergic reaction? what is the patient¿s current status? if applicable, will product be returned, return date, tracking information?.
Event or Problem Description
It was reported that a patient underwent a laparoscopic thyroid lobectomy/para thyroid procedure on (b)(6) 2019 and an absorbable hemostat was used.Post operatively, the patient had an allergic reaction.At the conclusion of the procedure the surgeon applied the absorbable hemostat at.025% bupivacaine with phrine.With in a few minutes the patient was noted as having erythema all around the incision site approximately ten centimeters in all directions.No erythema was noted prior to applying the absorbable hemostat.The patient was treated with oral and topical steroids, in addition to benadryl.Additional information was requested.

• Brand Name: SURGICEL SNOW 1INX2IN(2.5CMX5.1CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9650774
• Report Number: 2210968-2020-00849
• Device Sequence Number: 1742752
• Product Code: LMG
• UDI-Device Identifier: 10705031063587
• UDI-Public: 10705031063587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2081
• Device Catalogue Number: 2081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention