MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-11 for PLEURADESIS DUSTING TUBE 8294.13 manufactured by Richard Wolf Gmbh.
| Report Number | 1418479-1997-00034 |
| MDR Report Key | 105546 |
| Report Source | 05 |
| Date Received | 1997-07-11 |
| Date of Event | 1997-06-05 |
| Date Mfgr Received | 1997-06-12 |
| Device Manufacturer Date | 1995-07-01 |
| Date Added to Maude | 1997-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURADESIS DUSTING TUBE |
| Generic Name | PLEURADESIS DUSTING TUBE |
| Product Code | KCL |
| Date Received | 1997-07-11 |
| Model Number | 8294.13 |
| Catalog Number | 8294.13 |
| Lot Number | A-G-U |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 102062 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 D 75438 KNITTLINGEN GM |
| Baseline Brand Name | PLEURADESIS DUSTING TUBE |
| Baseline Generic Name | DUSTING TUBE |
| Baseline Model No | 8294.13 |
| Baseline Catalog No | 8294.13 |
| Baseline ID | A-G-U |
| Baseline Device Family | PLEURADESIS DUSTING TUBE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-11 |