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 2018-04-25 for UROVAC? BLADDER EVACUATOR M0067301251 730-125 manufactured by Boston Scientific - Spencer.
[106650506]
(b)(4). 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
[106650507]
It was reported to boston scientific corporation that a bladder evacuator device was unpacked on (b)(6) 2018. According to the complainant, during unpacking, the packaging of the device was noted to be damaged. It was noticed that the packaging has a cut. Reportedly, this was not used in a patient. Attempts to obtain additional information regarding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted. No patient complications have been reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01284 |
| MDR Report Key | 7462373 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2017-07-11 |
| Date Added to Maude | 2018-04-25 |
| 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 - SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| 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 | 2018-04-25 |
| Model Number | M0067301251 |
| Catalog Number | 730-125 |
| Lot Number | 20872043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-25 |