MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for LATERA DELIVERY DEVICE / ABSORBABLE NASAL IMPLANT LATDD24 manufactured by Spirox, Inc..
[130633006]
When attempting to deploy the later implant into left nare, the implant would not deploy. And would pull out when removing the injector x2. A new implant was obtained/ deployed without incident. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082125 |
| MDR Report Key | 8164588 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-30 |
| Date Added to Maude | 2018-12-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LATERA DELIVERY DEVICE / ABSORBABLE NASAL IMPLANT |
| Generic Name | POLYMER EAR, NOSE AND THROAT, SYNTHETIC ABSORBABLE |
| Product Code | NHB |
| Date Received | 2018-12-13 |
| Catalog Number | LATDD24 |
| Lot Number | 062018-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIROX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-13 |