MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-13 for COLPASSIST? M0068318210 831-821 manufactured by Boston Scientific - Marlborough.
[77518939]
The device has been received for analysis. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[77518940]
It was reported to boston scientific corporation that a colpassist? Was to be used during a mid-urethral sling procedure performed on (b)(6) 2017. According to the complainant, during preparation, there was a black foreign matter with the device inside the package. The device was not used on a patient. The procedure was completed with another colpassist?. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-01746 |
| MDR Report Key | 6639251 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2017-04-06 |
| Date Added to Maude | 2017-06-13 |
| 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 |
| 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 | PROXY BIOMEDICAL LIMITED |
| Manufacturer Street | COILLEACH SPIDDAL |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLPASSIST? |
| Generic Name | MESH, SURGICAL, SYNTHETIC |
| Product Code | KOH |
| Date Received | 2017-06-13 |
| Returned To Mfg | 2017-06-01 |
| Model Number | M0068318210 |
| Catalog Number | 831-821 |
| Lot Number | C003369 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |