MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-08 for PORGES WOVEN STRAIGHT FILLIFORM, 18" CH06FR manufactured by Rusch, Inc..
[10314]
Filiform broke off during dilation procedure, resulting in all but 2 cm of the filiform being left behind in the bladder. Pt had to go to or under anesthesia to have filiform removed. Hosp found one add'l unit of this lot. A technician carefully bent the filiform at about the same spot where the first one broke. This second unit broke also. Then the same procedure was tried on one of a different lot. That one did not break. The break occurred at the end of the filiform where a screw attachment is embedded and which accomodates a catheter to provide extra strength (can screw attachment and to a cath). The broken unit (suspect unit and one tested by the hosp tech) will be sent to co for further examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000611 |
| MDR Report Key | 18887 |
| Date Received | 1994-12-08 |
| Date of Report | 1994-12-08 |
| Date Added to Maude | 1995-01-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORGES WOVEN STRAIGHT FILLIFORM, 18" |
| Product Code | FBW |
| Date Received | 1994-12-08 |
| Model Number | CH06FR |
| Lot Number | 920913 |
| Device Expiration Date | 1997-09-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18814 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | DULUTH GA 30136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-12-08 |