MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-08-25 for H.E.L.P 7068875 manufactured by B. Braun Medical, Inc..
[412559]
Patient experienced a non fatal mi in 2005. Recovered with treatment the 5th day. Additional information received from nurse at the user facility indicated the cause of the mi was in relation to a 90% blockage in the arteries. She reported that the patient's heart attack had no relation to the h. E. L. P machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2005-00052 |
| MDR Report Key | 631184 |
| Report Source | 06 |
| Date Received | 2005-08-25 |
| Date of Report | 2005-08-08 |
| Date of Event | 2005-06-08 |
| Date Mfgr Received | 2005-07-26 |
| Date Added to Maude | 2005-08-30 |
| 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 Contact | KIKOO TEJWANI |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | H.E.L.P |
| Generic Name | LDL- APHERESIS SYSTEM |
| Product Code | MMY |
| Date Received | 2005-08-25 |
| Model Number | NA |
| Catalog Number | 7068875 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 620779 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | * ALLENTOWN PA 18109 US |
| Baseline Brand Name | H.E.L.P. |
| Baseline Generic Name | LDL - APHERESIS SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 7068875 |
| Baseline ID | NA |
| Baseline Device Family | LDL - APHERESIS SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9400 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-25 |