MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for VENTRIC.CATH.RADIOPAQUE 250MM FV077P manufactured by Christopher Methke Gmbh & Co. Kg.
[139417868]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139417869]
It was reported by the healthcare professional "ventricular catheter was found to be deformed when opening the package in the surgical procedure. Upon removal of the stylet of the catheter, the catheter itself is bent at its tip, and it was not good for clinical use. The surgeon used a replacement catheter. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2019-00073 |
| MDR Report Key | 8433472 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-03-04 |
| Date Facility Aware | 2019-03-15 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOERG KNEBEL |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, MO 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal | 14469 |
| Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTRIC.CATH.RADIOPAQUE 250MM |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | HAO |
| Date Received | 2019-03-19 |
| Model Number | FV077P |
| Catalog Number | FV077P |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTOPHER METHKE GMBH & CO. KG |
| Manufacturer Address | 2 ULANENWEG POTSDAM D, 14469 GM 14469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |