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 2018-12-13 for SYMPHION UNK-M-74052 74052 manufactured by Boston Scientific Corporation.
[130320801]
Date of event: date of event was approximated to? (b)(6) 2018? As no event date was reported. The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[130320802]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion fluid management accessory kit was used during a procedure performed on an unknown date. According to the complainant, after the procedure, the nurse opened the tissue catch to access the specimen for pathology. There was pressure in the system and it splashed on the nurse. There were no serious injury/adverse effect to patient or user as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61924 |
| MDR Report Key | 8162080 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-12-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | SMC COSTA RICA |
| Manufacturer Street | EDIFICIO B48 AVENIDA 0 , |
| Manufacturer City | ZONA FRANCA COYOL, ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMPHION |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA |
| Product Code | PGT |
| Date Received | 2018-12-13 |
| Model Number | UNK-M-74052 |
| Catalog Number | 74052 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |