MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-13 for LEECHES BM manufactured by Ricarimpex.
[79975727]
Manufacturing records including acceptance testing results were checked and found to be conforming to specifications. Since the user found the lot to be conforming upon receipt and the pseudomonas appeared subsequently, the issue may be related to deficient hospital storage procedures. In addition, it is known that trimethoprim/sulfamethoxazole is ineffective against pseudomonas. Return of the device has been requested. Device not yet available. If additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[79975728]
During routine testing of leeches for antibiotic resistance by the user (healthcare facility) at the moment of receipt and after several days of storage, the user detected: -lot conforming to specifications at reception on (b)(6) 2017 (shipping water):. -trimethoprim/sulfamethoxazole-resistant pseudomonas aeruginosa detected during routine retesting of lot on (b)(6) 2017 (hospital storage water). This lot was subsequently used during clinical procedures on multiple patients, who did not suffer adverse consequences, i. E. , no infection of operating site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009106257-2017-00001 |
| MDR Report Key | 6710624 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-13 |
| Date of Report | 2017-07-13 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2017-07-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONIA BARBE |
| Manufacturer Street | 245, AVENUE DE SAINT MEDARD |
| Manufacturer City | 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal | 33320 |
| Manufacturer G1 | RICARIMPEX |
| Manufacturer Street | 245 AVENUE DE SAINT MEDARD |
| Manufacturer City | 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEECHES |
| Generic Name | LEECHES HIRUDO MEDICINALIS |
| Product Code | NRN |
| Date Received | 2017-07-13 |
| Model Number | BM |
| Lot Number | 17/043/B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICARIMPEX |
| Manufacturer Address | 245, AVENUE DE SAINT MEDARD EYSINES, AQUITAINE 33320 FR 33320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-13 |