MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[183895016]
Disposable valvulotome was opened for vascular bypass surgery. Circulator forgot to check for latex-free compatability. Packaging does not specify whether latex is present. After discovery, the company was called and it was confirmed that this product does contain latex. The surgeon and anesthesiologist were made aware and our monitoring the patient. We are adding a symbol next to this item in our supplies to signal the presence of latex. Manufacturer response for valvulotome, (brand not provided) (per site reporter). The device does contain latex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847340 |
| MDR Report Key | 9847340 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-23 |
| Report Date | 2020-01-28 |
| Date Reported to FDA | 2020-01-28 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2020-03-18 |
| Model Number | 1009-00 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1349V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |