MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-14 for UROVAC? BLADDER EVACUATOR M0067301251 730-125 manufactured by Boston Scientific - Costa Rica (coyol).
[86148065]
The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. It was reported the device was not used past its expiry date. The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[86148066]
It was reported to boston scientific corporation that a urovac bladder evacuator was used on a procedure performed two and half year ago. According to the complainant, the patient suffered an injury due to a urology device used in a gynecological procedure. However, the nature and cause of the injury is unknown. No patient complications have been reported as a result of this event. Attempts to obtain additional patient and procedure information have been unsuccessful. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02788 |
| MDR Report Key | 6865340 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-24 |
| Date Mfgr Received | 2017-08-24 |
| Date Added to Maude | 2017-09-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROVAC? BLADDER EVACUATOR |
| Generic Name | EVACUATOR, BLADDER, MANUALLY OPERATED |
| Product Code | FFD |
| Date Received | 2017-09-14 |
| Model Number | M0067301251 |
| Catalog Number | 730-125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-14 |