MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-08-03 for LYMPHAZURIN 1% DYE LYM 100 manufactured by United States Surgical.
[17173569]
Reportedly, approx 5 to 10 minutes after injection of the lymphazurin 1% dye the pt developed hives, redness, and swelling over their entire body. Solumedrol 125mg iv and dipenhydramine 50 mg iv was administered to the pt. The pt then experienced a hypotensive episode. The pt was then transferred to the local emergency dept where pt was given pepcid and treated for abdominal pains. Pt status is reported as improved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2001-00364 |
| MDR Report Key | 345904 |
| Report Source | 05,06 |
| Date Received | 2001-08-03 |
| Date of Report | 2001-07-27 |
| Date of Event | 2001-07-25 |
| Date Facility Aware | 2001-07-25 |
| Date Mfgr Received | 2001-07-27 |
| Date Added to Maude | 2001-08-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA ROEPE, RN, MA, CEN |
| Manufacturer Street | 195 MCDERMOT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926334 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYMPHAZURIN 1% DYE |
| Generic Name | LYMPHATIC MAPPING DYE |
| Product Code | LEF |
| Date Received | 2001-08-03 |
| Model Number | NA |
| Catalog Number | LYM 100 |
| Lot Number | W1001 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 335233 |
| Manufacturer | UNITED STATES SURGICAL |
| Manufacturer Address | 195 MCDERMOTT RD. NORTH HAVEN CT 06473 US |
| Baseline Brand Name | LYMPHAZURIN 1% BLUE DYE |
| Baseline Generic Name | LYMPHATIC MAPPING DYE |
| Baseline Model No | NA |
| Baseline Catalog No | LYM 100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-08-03 |