MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-06 for SEPRAGEL SINUS * 7089-0812 manufactured by Genzyme Biosurgery.
[468527]
Pt developed tingling and numbness of the right face four days after using sepragel sinus during tympanoplasty. Sepragel sinus was used to fill the middle ear to hold the graft. He later developed total paralysis of the right face 6 days following tympanoplasty. He had a magnetic resonance imaging -mri- 1 week after the right facial paralysis and an enhancing soft tissue fills the right tympanic cavity and portions of the mastoid which i think represents the sepragel sinus used during the procedure. This abuts and obsures the tympanic and mastoid segments of the facial nerve. He was given decadron 10 mg i. V. Followed by prednisone for 3 weeks and famvir for 10 days. He recovered uneventfully 1 week later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038220 |
| MDR Report Key | 692755 |
| Date Received | 2006-03-06 |
| Date of Report | 2006-03-06 |
| Date of Event | 2005-12-03 |
| Date Added to Maude | 2006-03-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEPRAGEL SINUS |
| Generic Name | HYALURONIC ACID - GEL FORM- |
| Product Code | KHJ |
| Date Received | 2006-03-06 |
| Model Number | * |
| Catalog Number | 7089-0812 |
| Lot Number | 805031 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 681907 |
| Manufacturer | GENZYME BIOSURGERY |
| Manufacturer Address | * CAMBRIDGE MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-06 |