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 BLUE DYE LYM 100 manufactured by United States Surgical Corporation.
[17435971]
Reportedly, the patient developed bronchial spasm, blue rash, hypotension following 5 ml sq dose of lymphazurin dye. The symptoms resolved after the administration of diphenhydramine. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2001-00349 |
| MDR Report Key | 342555 |
| Report Source | 05,06,07 |
| Date Received | 2001-07-17 |
| Date of Report | 2001-07-13 |
| Date of Event | 2001-06-15 |
| Date Facility Aware | 2001-06-15 |
| Date Reported to FDA | 2001-06-18 |
| Date Reported to Mfgr | 2001-06-18 |
| Date Mfgr Received | 2001-07-13 |
| Device Manufacturer Date | 2000-09-01 |
| 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 BLUE DYE |
| Generic Name | LYMPHATIC MAPPING DYE |
| Product Code | LEF |
| Date Received | 2001-07-17 |
| Model Number | NA |
| Catalog Number | LYM 100 |
| Lot Number | W0J02A |
| ID Number | NA |
| Device Expiration Date | 2002-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 331893 |
| 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 |