MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-14 for MEDCOMP PD CATH MPD-257 * manufactured by Mps Medical Product Service Gmbh.
[627253]
Peritoneal catheter tunneler broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042878 |
| MDR Report Key | 853065 |
| Date Received | 2007-05-14 |
| Date of Report | 2007-05-14 |
| Date of Event | 2007-05-14 |
| Date Added to Maude | 2007-05-22 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDCOMP PD CATH |
| Generic Name | PERITONEAL DIALYSIS CATHETER KIT WITH TWO CUFFS |
| Product Code | LFK |
| Date Received | 2007-05-14 |
| Model Number | MPD-257 |
| Catalog Number | * |
| Lot Number | MAGN880 |
| ID Number | * |
| Device Expiration Date | 2011-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 839096 |
| Manufacturer | MPS MEDICAL PRODUCT SERVICE GMBH |
| Manufacturer Address | * BRAUNFEIS GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-14 |