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 |