MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-26 for LATERA ABSORBABLE NASAL IMPLANT LATANI02 manufactured by Spirox, Inc..
[95790195]
The device manufacture date and lot number is not known at this time. However, should it become available, it will be provided in future reports.
Patient Sequence No: 1, Text Type: N, H10
[95790196]
It was reported that a patient presented approximately six (6) weeks after a bilateral implant procedure with an abscess along the left lateral nasal wall coincident with the forks of the latera absorbable nasal implant. No problems were reported on either side of the nose during the two-week post implantation follow-up visit or on the right side of the nose at six (6) weeks post implantation. The physician incised and drained the abscess and packed the wound, with the implant in situ. When the physician removed the packing the implant forks came out with the packing material. At approximately eight (8) weeks post implantation the patient returned for follow up with some swelling. The physician removed the remainder of the implant, which had migrated superiorly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011238988-2017-00007 |
| MDR Report Key | 7146705 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-26 |
| Date of Report | 2017-12-26 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-12-26 |
| 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 | MS MELISSA VIOTTI |
| Manufacturer Street | 595 PENOBSCOT DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6504358104 |
| Manufacturer G1 | SPECTRUM PLASTICS GROUP |
| Manufacturer Street | 7309 WEST 27TH ST. |
| Manufacturer City | MINNEAPOLIS MN 55426 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55426 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATERA ABSORBABLE NASAL IMPLANT |
| Generic Name | LATERA ABSORBABLE NASAL IMPLANT |
| Product Code | NHB |
| Date Received | 2017-12-26 |
| Model Number | LATANI02 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIROX, INC. |
| Manufacturer Address | 595 PENOBSCOT DRIVE REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-26 |