MAUDE Adverse Event Report: SINUSAFE MEDICAL LTD SINUSAFE

Catalog Number SNS-1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

The physician assumed that the periorbital swelling is related to the patient's facial trauma history, which allowed the drug application pressure to escape the sinus cavity.The device was inspected by the company's representative after the procedure, and was found intact.No malfunction was detected.Per clinical opinion of this occurrence, it seems that the periorbital swelling that occurred after drug application is linked to the patient's facial trauma history that allowed the drug application pressure to escape the sinus cavity into the eyelid.The combination of the drug's jelly-like state which required higher pressure during application and the unique physiological structure of the patient, following facial trauma, apparently led to the occurrence.Based on this information, device inspection and occurrence circumstances, it is not likely that the occurrence is device related.

Event Description

After maxillary sinus irrigation with a sinusafe device, and after compounded drug application into the sinus, the physician noted periorbital swelling.During application, the drug was not in a liquid state but in a jelly-like state.The treatment was performed under general anesthesia.The compound applied was cpd lev/bud 100mg-0.5mg/10mg, lot number: 4476510, compounded by (b)(6).Upon noticing the periorbital swelling by the user (ent physician), the patient was treated with lamina papyracea puncturing to relieve eye pressure and sent for ophthalmology examination.The ophthalmology examination included a physician check-up and ct scan.The physician reported to the company's representative that the examination verified no orbital damage and no vision damage.He also reported that the ct scan showed that the drug was positioned correctly in the bottom of the maxillary sinus cavity confirming that the drug was administered into the sinus cavity as intended and did not penetrate into the eye cavity.The patient did not require hospitalization.She reported to the physician a history of facial trauma.According to the physician report to the company's representative, the swelling was noted to improve since the procedure as of (b)(6) 2020.No additional intervention was performed.

• Brand Name: SINUSAFE
• Type of Device: SINUSAFE
• Manufacturer (Section D): SINUSAFE MEDICAL LTD; 6 yoni netanyahu st.; or yehuda, tel-aviv 60376 04; IS 6037604
• Manufacturer (Section G): TARYAG STERILIZATION LTD; po box 148; 14 ha'ilan st.; or akiva, 30651 01; IS 3065101
• Manufacturer Contact: avinoam gemer ; 6 yoni netanyahu st.; or yehuda, tel-aviv 60376-04 ; IS 6037604
• MDR Report Key: 10999172
• MDR Text Key: 221238653
• Report Number: 3014269548-2020-00001
• Device Sequence Number: 1
• Product Code: LRD
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Catalogue Number: SNS-1001
• Device Lot Number: SINU20005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 12/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 60