MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Arista AH; Agent, absorbable hemostatic, non collagen based

Catalog Number	SM0002-USA
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a cholecystitis procedure, arista ah was applied to the hepatic fossa, which was bleeding during dissection.Reportedly, fifteen (15) minutes later, while irrigating the wound, erythematous papules were observed on the patient's left and right flanks and lower abdomen.There were no changes in vital signs or other parameters.Medication was implemented on the spot to alleviate the hives.Residual material was removed, the patient was discharged after the hives subsided.The patient's condition has progressed favorably.It is unclear whether the hives were an allergic reaction to arista ah, but the only deviation from standard supplies was the use of arista.
Additional Manufacturer Narrative
As reported, during cholecystitis, arista ah was applied to the hepatic fossa, fifteen minutes later, while irrigating the wound, erythematous papules were observed on the patient's left and right flanks and lower abdomen.Medication was implemented on the spot to alleviate the hives.However, based on the information provided, no conclusion can be made as to what if any extent the arista ah may have caused or contributed to the patient's postoperative course.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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
• Manufacturer (Section G): Davol Inc. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; +1(800)556-6756
• MDR Report Key: 50059451
• Report Number: 1213643-2026-00960
• Device Sequence Number: 10665762
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106(17)301128(10)8366201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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: SM0002-USA
• Device Lot Number: 8366201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown