MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-08-03 for LATERA ABSORBABLE NASAL IMPLANT LATANI02 manufactured by Spirox, Inc..
[115962939]
It was reported that approximately two (2) days post bilateral lateral implant procedure, the patient experienced pain and yellow and green pus on the right side of the nose and swelling and redness on the left side, coincident with the implants. It was also reported that the physician prescribed augmentin and removed the implant on the right side through the original implantation pierce point. Attempts were made to obtain additional information about the event; no further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011238988-2018-00001 |
| MDR Report Key | 7748064 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-06-16 |
| Date Mfgr Received | 2018-07-05 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2018-08-03 |
| 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 | SPIROX, INC. |
| Manufacturer Street | 595 PENOBSCOT DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94063 |
| 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 | 2018-08-03 |
| Model Number | LATANI02 |
| Lot Number | 202156 |
| Device Expiration Date | 2019-02-01 |
| 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 | 2018-08-03 |