MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-03-29 for UPSYLON? UNK760 manufactured by Boston Scientific - Marlborough.
[71164035]
There were two hospitals reported with this event; it is unknown where the bsc device was implanted: (b)(6) health center. (b)(6) medical center, (b)(6) campus.
Patient Sequence No: 1, Text Type: N, H10
[71164036]
As reported by the patient? S attorney, an upsylon y-mesh was implanted. According to the complainant, the patient experienced an unknown injury. All other information is unknown. Should additional relevant details become available; a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005099803-2017-00728 |
MDR Report Key | 6443351 |
Report Source | COMPANY REPRESENTATIVE,CONSUM |
Date Received | 2017-03-29 |
Date of Report | 2017-03-01 |
Date Mfgr Received | 2017-03-01 |
Date Added to Maude | 2017-03-29 |
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 |
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 | UPSYLON? |
Generic Name | MESH, SURGICAL, SYNTHETIC |
Product Code | KOH |
Date Received | 2017-03-29 |
Model Number | UNK760 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
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 | 1. Other | 2017-03-29 |