MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-07-17 for LYMPHAZURIN 1% BLUE DYE LYM 100 manufactured by United States Surgical Corporation.
[244840]
Reportedly, the patient experienced severe hypotension following sq administration of lymphazurin dye. The patient was treated with hydrocortisone, epinephrine, diphenhydramine, and transferred to icu for monitoring. The symptoms resolved with no untoward sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2001-00350 |
| MDR Report Key | 342504 |
| Report Source | 05,06,07 |
| Date Received | 2001-07-17 |
| Date of Report | 2001-07-13 |
| Date of Event | 2001-06-14 |
| Date Facility Aware | 2001-06-14 |
| Date Reported to FDA | 2001-06-18 |
| Date Reported to Mfgr | 2001-06-18 |
| Date Mfgr Received | 2001-07-13 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2001-07-20 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 MCDERMOTT ROAD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926334 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * 203 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYMPHAZURIN 1% BLUE DYE |
| Generic Name | LYMPHATIC MAPPING DYE |
| Product Code | LEF |
| Date Received | 2001-07-17 |
| Model Number | NA |
| Catalog Number | LYM 100 |
| Lot Number | W0L02 |
| ID Number | NA |
| Device Expiration Date | 2002-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 331842 |
| Manufacturer | UNITED STATES SURGICAL CORPORATION |
| 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 | 2001-07-17 |