Arista AH

Description of Event or Problem

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.