ARISTA AH
Received Jul 13, 2026 · Event occurred Jun 29, 2026
Report 1213643-2026-00905 · MDR key 25796765
Device
Generic name
Agent, Absorbable Hemostatic, Non Collagen Based
Manufacturer
Davol Inc., Sub. C.r. Bard, Inc. -1213643Model number
NACatalog number
SM0002
Lot number
NI
Product problems
- Patient-Device Incompatibility
Patient
NA · Unknown
- Unspecified Respiratory Problem
Narrative
Additional Manufacturer Narrative
AS REPORTED, PATIENT UNDERWENT A PROCEDURE USING ARISTA AH, AND POST-SURGERY PATIENT DEVELOPED RESPIRATORY DISEASE. 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 RESPIRATORY DISEASE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORD IS NOT POSSIBLE. 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.
Description of Event or Problem
AS REPORTED, PATIENT UNDERWENT A PROCEDURE USING ARISTA AH, AND POST-SURGERY PATIENT DEVELOPED RESPIRATORY DISEASE.