MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-06-19 for LEECHES LE2000 manufactured by Leeches U.s.a. Ltd..
[19649078]
To date we have not been able to confirm that the leeches involved in this event were supplied by (b)(4). Leeches have never been supplied to (b)(6). Attempts to obtain add'l info are ongoing and will be communicated, if successful, by means of a follow-up report. Infection from outside sources, including the air, water and the leech itself, is a well-known risk to pts receiving leech therapy. Prophylaxis with an appropriate antibiotic is recommended by specialized studies. A warning to this effect is included on page 4 of our package insert, as well as a list of antibiotics on page 6, as required and cleared by fda for (b)(4). The package insert consisting of instruction for use and a list of antibiotics against aeromonas hydrophila is included with every shipment of leeches. Coincidentally with the event, our package insert was revised to correct the statement that had previously identified ciprofloxacin, trimethoprim/sulfamethozazole and cefotaxime incorrectly as third generation cephalo-sporins. However, we consider that this erroneous statement could not have contributed to the event assuming that our leeches were involved and that our previous insert was consulted, since the antibiotics thus identified have been -and continue to be- amply recommended for prophylaxis by specialized studies regarding the risk of infection concomitant to leech therapy. We are including a current copy of our package insert with this report and will continue our attempts to clarify the circumstances pertaining to this event.
Patient Sequence No: 1, Text Type: N, H10
[19659264]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2419564-2012-00001 |
| MDR Report Key | 2632688 |
| Report Source | 00,05 |
| Date Received | 2012-06-19 |
| Date Mfgr Received | 2012-05-21 |
| Date Added to Maude | 2012-06-29 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIE BONAZINGA |
| Manufacturer Street | 300 SHAMES DR. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5163332570 |
| Manufacturer G1 | RICARRIMPEX |
| Manufacturer Street | 245 AVENUE DE SAINT MEDARD |
| Manufacturer City | EYSINES 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33320 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEECHES |
| Generic Name | LEECHES |
| Product Code | NRN |
| Date Received | 2012-06-19 |
| Model Number | LE2000 |
| Catalog Number | LE2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEECHES U.S.A. LTD. |
| Manufacturer Address | WESTBURY NY 11590 US 11590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-19 |