MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-11-04 for STIMD2280/15 333674 manufactured by B. Braun Medical, Inc..
[353241]
Experienced much difficulty with guiding the needle through the skin, resulted in puncturing the external jugular vein, pressure applied, approx. 1 inch area of hematoma developed (pt on plavix).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2004-00077 |
| MDR Report Key | 553827 |
| Report Source | 06 |
| Date Received | 2004-11-04 |
| Date of Report | 2004-11-02 |
| Date of Event | 2004-09-30 |
| Date Mfgr Received | 2004-10-04 |
| Date Added to Maude | 2004-11-09 |
| 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 | NA |
| Generic Name | INSULATED NEEDLE FOR USE WITH STIMUPLEX |
| Product Code | BXN |
| Date Received | 2004-11-04 |
| Model Number | STIMD2280/15 |
| Catalog Number | 333674 |
| Lot Number | UNK |
| 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 | 543460 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | * ALLENTOWN PA 18109 US |
| Baseline Brand Name | NA |
| Baseline Generic Name | INSULATED NEEDLE FOR USE WITH STIMUPLEX NERVE STIMULATOR |
| Baseline Model No | STIMD2280/15 |
| Baseline Catalog No | 333674 |
| Baseline ID | NA |
| Baseline Device Family | STIMUPLEX NEEDLES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K860126 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-04 |