MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-25 for FLIFORM WITH SPIRAL TIP AG5L06 manufactured by Rusch, Inc..
[25205]
Tip broke off in pt. Product previously used and had been resterilized.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2429473-1996-00005 |
MDR Report Key | 34911 |
Date Received | 1996-07-25 |
Date of Report | 1996-07-12 |
Date of Event | 1996-07-12 |
Date Facility Aware | 1996-07-12 |
Report Date | 1996-07-12 |
Date Reported to FDA | 1996-07-12 |
Date Reported to Mfgr | 1996-07-12 |
Date Added to Maude | 1996-08-06 |
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 | FLIFORM WITH SPIRAL TIP |
Generic Name | URETHERAL FILIFORM |
Product Code | FBW |
Date Received | 1996-07-25 |
Model Number | NA |
Catalog Number | AG5L06 |
Lot Number | 940509 |
ID Number | NA |
Device Expiration Date | 1999-01-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 24 MO |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 36311 |
Manufacturer | RUSCH, INC. |
Manufacturer Address | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1996-07-25 |