MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-08 for MEROGEL NASAL DRESSING & SINUS STENT 15-17000 manufactured by Fab S.r.l..
[20683417]
Pt brought back in three days after surgery because the doctor believes merogel caused infection by blocking the "natural osteon".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2000-00023 |
| MDR Report Key | 311083 |
| Date Received | 2001-01-08 |
| Date of Report | 2000-12-07 |
| Date of Event | 2000-01-01 |
| Date Facility Aware | 2000-12-07 |
| Report Date | 2001-01-08 |
| Date Reported to FDA | 2001-01-08 |
| Date Reported to Mfgr | 2001-01-08 |
| Date Added to Maude | 2001-01-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEROGEL NASAL DRESSING & SINUS STENT |
| Generic Name | NASAL PACKING |
| Product Code | EPP |
| Date Received | 2001-01-08 |
| Model Number | NA |
| Catalog Number | 15-17000 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 300911 |
| Manufacturer | FAB S.R.L. |
| Manufacturer Address | VIA POINTE DELLA FABBRICA, 3/A ABANO TERME (PD) IT 35031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-01-08 |