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 |