MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-09-25 for LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1 LATANI02 manufactured by Spirox, Inc..
[121587202]
Discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[121587203]
It was reported that six (6) days after a bilateral implant procedure that the patient experienced pain above the bridge of the nose at the location of the implant distal forks. It was also reported that the patient experience pain, especially while wearing glasses. It was further reported that the left side of the patient? S nose became infected and caused difficulty breathing out of the left nostril. The patient requested implant removal. It is reported that prior to removal, when looking at the patients outward appearance there was visible irritation on the left side of the nasal dorsum only; the right side looked atypical. It is reported that the doctor opted to retrieve both implants without replacing. The retrieval itself was reported to happen without incident on both sides.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011238988-2018-00002 |
| MDR Report Key | 7905614 |
| Report Source | OTHER |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-28 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2018-09-25 |
| 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 | MR. LISA SIMS |
| Manufacturer Street | 595 PENOBSCOT DR |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6505033329 |
| Manufacturer G1 | SPIROX, INC. |
| Manufacturer Street | 595 PENOBSCOT DR |
| 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 2 IMPLANTS GEN 1 |
| Generic Name | LATERA ABSORBABLE NASAL IMPLANT |
| Product Code | NHB |
| Date Received | 2018-09-25 |
| Catalog Number | LATANI02 |
| Lot Number | 204553 |
| Device Expiration Date | 2019-05-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIROX, INC. |
| Manufacturer Address | 595 PENOBSCOT DR REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-25 |