MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-20 for MEROGEL NASAL DRESSING & SINUS STENT 2/BX * 15-17002 manufactured by Fab S.r.l..
[20925978]
User facility reported: merogel caused severe tissue reaction to pt. Pt returned to or-reactive polypoid tissue debrided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2000-00022 |
| MDR Report Key | 309116 |
| Date Received | 2000-12-20 |
| Date of Report | 2000-11-02 |
| Date of Event | 2000-10-02 |
| Date Facility Aware | 2000-11-04 |
| Report Date | 2000-12-20 |
| Date Reported to FDA | 2000-12-20 |
| Date Reported to Mfgr | 2000-12-20 |
| Date Added to Maude | 2000-12-21 |
| 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 2/BX |
| Generic Name | NASAL PACKING |
| Product Code | EPP |
| Date Received | 2000-12-20 |
| Model Number | * |
| Catalog Number | 15-17002 |
| Lot Number | 011110 |
| ID Number | NA |
| Device Expiration Date | 2004-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 299086 |
| 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 | 2000-12-20 |