MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-10-25 for FILIFORM UNK manufactured by Rusch, Inc..
[19892280]
The customer reports that while attempting to insert a filliform the material was not rigid enough to pass the prostate. The material would "crinkle up". No injury was caused by the "crinkling". Various sizes (not identified) were attempted, all with the same results. Pt was taken to surgery to have a different instrument used to pass the catheter. Customer reports that this occurred on two separate occassions, but no specific info about the event was available. Customer was unable to identify the size(s) or style(s) of filiform used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-2000-00089 |
| MDR Report Key | 302457 |
| Report Source | 05 |
| Date Received | 2000-10-25 |
| Date of Report | 2000-10-23 |
| Date Mfgr Received | 2000-10-04 |
| Date Added to Maude | 2000-11-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | KATRINA HALBIG, QUALITY ADMIN |
| Manufacturer Street | 2450 MEADOWBROOK PKWY |
| Manufacturer City | DULUTH GA 30136 |
| Manufacturer Country | US |
| Manufacturer Postal | 30136 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILIFORM |
| Generic Name | FILIFORM |
| Product Code | FBW |
| Date Received | 2000-10-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 292743 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-25 |