MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-05-17 for INTERNAL NASAL SPLINT - DOYLE II 1524055 manufactured by Medtronic Xomed, Inc.
[45322555]
The device was not returned. Patients in all groups experienced early hemorrhage, hematoma, synechia, infection, and perforation. These are expected potential post-op complications with any septoplasty, regardless of the packing or splinting device used, and will vary depending on the patient? S anatomy, intra-operative techniques and practices, individual capacity for healing, and post-op care/hygiene. There are no allegations or evidence that the medtronic product caused or contributed to any of the post-op complications. Removal of synechia is not done to prevent serious injury or death. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[45322556]
It was reported that a research study was done to observe if there is a difference in the frequency of typical post-op complications based on the post-op timing of splint removal. A medtronic product was included in this study. In the article, titled "optimal time for intranasal splint removal after septoplasty: a prospective clinical study" by fatih ozdogan, et al, patients in all groups experienced early hemorrhage, hematoma, synechia, infection, and perforation. The patient with infection was treated with parenteral antibiotics. A patient that experienced a septal hematoma was hospitalized and was also given parenteral antibiotics, and hematoma drainage was performed. Of note, the patient that experienced early hemorrhage did not require medical intervention or treatment. Synechia (healing scar tissue) between the septum and inferior concha was removed under local anesthesia.
Patient Sequence No: 1, Text Type: D, B5
[101833579]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00154 |
| MDR Report Key | 5660395 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-22 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-05-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| Manufacturer G1 | MEDTRONIC XOMED, INC |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERNAL NASAL SPLINT - DOYLE II |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-05-17 |
| Model Number | 1524055 |
| Catalog Number | 1524055 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-17 |