MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	SM0005-USA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Reaction (2414)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient had post-op development of rash outside of the dressing area after use of arista ah.The surgeon reports the patient may be having a response to the betadine skin preparation, however could not rule out the arista ah as a factor.Based on the information provided to date, no conclusion can be made as to the degree to which the arista ah, may be causing or contributing the patient¿s reported symptoms.No lot number has been provided, therefore, a review of the manufacturing records is not possible.Note: the date of event is provided as an estimate, based on the contact's information.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
As reported, the patient was treated for thyroid case during which 1g bellow of arista ah was used as a hemostatic agent.The arista ah was applied to the site but there was no active bleeding.As reported, the excess arista product was not irrigated out after hemostasis.The wound was closed.There were no immediate complications.A few days following surgery the patient developed post op rash and swelling outside the dressing area.It was in the area of the neck, chest and extremities.Surgeon stated that it feels the arista is most likely the issue.Patient was treated with prednisone steroids and doctor stated the patient was slowly improving.It was identified that there was no infection.The issue was a skin rash, reaction type response.Doctor could not rule out arista ah as a factor but did indicate that it may have been response to betadine skin preparation.

• Brand Name: ARISTA AH
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10711457
• Report Number: 1213643-2020-20020
• Device Sequence Number: 3933057
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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 Catalogue Number: SM0005-USA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention