MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XOM UNKNOWN ENDO

Model Number XOM UNKNOWN ENDO

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Cellulitis (1768); Feeding Problem (1850); Swelling (2091); Discharge (2225); Nasal Obstruction (2466)

Event Type  Injury  

Event Description

From the article published in the journal "ent ¿ ear, nose <(>&<)> throat journal" in september 2014 entitled "comparative study of intranasal septal splints and nasal packs in patients undergoing nasal septal surgery,¿ by raman wadhera, ms; naushad zafar, ms; sat paul gulati, ms; vijay kalra, ms; anju ghai, md.It was reported that the medtronic reuter bivalve intranasal splint was used after septoplasty procedures for 30 patients with a symptomatic deviation of the nasal septum.The medtronic reuter bivalve intranasal splint patients were only 1 of 2 groups in the study, which consisted of 25 males and 5 females with a mean age of 23.3 years.The patients were assessed for pain, discomfort and complications postoperatively at 24 and 48 hours, 1 week and 6 weeks (note: at 6 weeks, patients were asked for their subjective assessment of complaints and were also examined endoscopically).Based on these factors, the following complications were identified postoperatively after 48 hours: nasal bleeding (3 patients), swelling over the face and nose (3 patients), nasal discharge (2 patients), nasal obstruction (7 patients), feeding difficulty (2 patients), tip cellulitis (10 patients)¿and the following complications were identified postoperatively at 6 weeks: residual deformity (2 patients) and nasal discharge (4 patients).These patient injuries are a ll known complications in septoplasty procedures recognized by the article.It was also concluded that the medtronic reuter bivalve intranasal splints result in less postoperative pain without increasing postoperative complications, and in addition to the ease, effectiveness, and safety of splinting ¿ make it a superior alternative to nasal packing after septal surgeries.

Manufacturer Narrative

(b)(4).This device is being reported from a literature review.No devices will be returned, therefore no evaluation could be performed.This device is used for therapeutic purposes.

• Brand Name: XOM UNKNOWN ENDO
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: jacklyn hayman ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9042812769
• MDR Report Key: 4348348
• MDR Text Key: 5177429
• Report Number: 1045254-2014-00336
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2014

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 Model Number: XOM UNKNOWN ENDO
• Device Catalogue Number: XOM UNKNOWN ENDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1