MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-09-23 for DORNIER EPOS ULTRA NA manufactured by Dornier Medtech America, Inc.
[318036]
Pt experienced swelling and skin necrosis on left foot during an "off-label" achilles tendonitis procedure. Physician used local anesthetic marcaine with epinephrine causing restriction of blood flow at treatment site. Also, pt appeared to have severe venous insufficiency problems in both feet which should have precluded the pt from treatment. Epos ultra device did not contribute to the adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611388-2003-00001 |
| MDR Report Key | 486433 |
| Report Source | 05,06 |
| Date Received | 2003-09-23 |
| Date of Report | 2003-09-22 |
| Date of Event | 2003-04-30 |
| Report Date | 2003-09-22 |
| Date Mfgr Received | 2003-09-15 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2003-10-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TIM THOMAS |
| Manufacturer Street | 1155 ROBERTS BLVD. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146163 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER EPOS ULTRA |
| Generic Name | ESWT |
| Product Code | NBN |
| Date Received | 2003-09-23 |
| Model Number | EPOS ULTRA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 475317 |
| Manufacturer | DORNIER MEDTECH AMERICA, INC |
| Manufacturer Address | 1155 ROBERTS BLVD. KENNESAW GA 30144 US |
| Baseline Brand Name | DORNIER EPOS ULTRA |
| Baseline Generic Name | ESWT |
| Baseline Model No | EPOS ULTRA |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DORNIER EPOS ULTRA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-23 |