MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-02-07 for * manufactured by Karl Storz Gmbh & Co. Kg.
[17053506]
According to the p. I. (principal investigator) who performed this procedure, this event was not related to the use of the fetoscope and a certain percentage of deaths, including intrauterine fetal death, is anticipated for ttts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2007-00002 |
| MDR Report Key | 814436 |
| Report Source | 05,06 |
| Date Received | 2007-02-07 |
| Date Added to Maude | 2007-02-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | MITTLESTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | HFA |
| Date Received | 2007-02-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 801927 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | MITTELSTRASSE 8 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-07 |