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 Codes	Hormonal Imbalance (4495); Hypocalcemia (4823)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that after using arista in 3 thyroidectomy surgeries, his patients presented hypoparathyroidism, which after about 3 months got normalized.These patients did not have this disability prior to the procedure and/or use of arista.Patient was provided with parathyroid hormone (pth) on the following day.The hypoparathyroidism were reported to have normalized about 3 months later.This mdr represents case/patient 2.
Additional Manufacturer Narrative
As reported, patient had hypoparathyroidism post usage of arista ah during thyroidectomy which became normal after 3 months.Hypoparathyroidism could also occur as a result of injury during surgery or manipulation of the thyroid or parathyroid gland during surgery.As such, no conclusion can be made to what if any extent the arista product used caused or contributed to the patient's postoperative course.Review of manufacturing records confirms product was manufactured to specification.This mdr represents the arista ah (patient/case #2).Additional mdrs were submitted to represent the arista ah (patient/case #1 and #3).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.H3 other text : used on patient.
Event or Problem Description
A surgeon reported that after using arista in 3 thyroidectomy surgeries, his patients presented hypoparathyroidism, which after about 3 months got normalized.These patients did not have this disability prior to the procedure and/or use of arista.Patient was provided with parathyroid hormone (pth) on the following day.The hypoparathyroidism were reported to have normalized about 3 months later.Addendum per additional information: it was reported that thyroidectomy surgeries were done on (b)(6) 2023.As reported on day 1 post operation, the patient was examined with parathyroid hormone and calcium dosage which detected hypoparathyroidism.It was also reported that the patient had symptoms of hypocalcemia, therefore prescribed with oral calcitonin and calcium.It was reported that the residual material of arista ah was not removed from patients.This mdr represents case/patient 2.
Additional Manufacturer Narrative
As reported, patient had hypoparathyroidism post usage of arista ah during thyroidectomy which became normal after 3 months.Hypoparathyroidism could also occur as a result of injury during surgery or manipulation of the thyroid or parathyroid gland during surgery.As such, no conclusion can be made to what if any extent the arista product used caused or contributed to the patient's postoperative course.Review of manufacturing records confirms product was manufactured to specification.Addendum: h11: this supplemental mdr is submitted to document the additional information provided and to correct the date of event.Updated fields: b4, b5, g3, g6, h2, h6, h10, h11.Corrected field: b3 (date of event).Note, the date of event (31-may-2023) is provided as an estimate based on the information provided.The warning section of the ifu states, "once hemostasis is achieved, excess arista ah should be removed from the site of application by irrigation and aspiration and also states, "arista ah swells to its maximum volume immediately upon contact with blood or other fluids.Dry, white arista ah should be removed." this supplemental mdr represents the arista ah (patient/case #2).Additional supplemental mdrs were submitted to represent the arista ah (patient/case #1 and #3).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.H3 other text : used on patient.

• 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 ; 8005566756
• MDR Report Key: 17735504
• Report Number: 1213643-2023-00331
• Device Sequence Number: 15120496
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 8011101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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: Required Intervention
• Patient Sex: Unknown