MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-27 for PSI-TEC III ASPIRATOR, 110V PT-ASP-III-110 manufactured by Mentor Texas.
[122008160]
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. Since no lot number was provided, no device history record (dhr) review could be performed. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122008161]
It was reported that during a procedure, fluid was being sent through the filter with blood and it was coming out of the bottom of unit. The filter was soaked in blood, fell to the floor and appeared to be coming out of the unit. Per reporter, there was no user or patient consequence or injury. Multiple attempts have been made to obtain additional details regarding this event. However, no additional information has been made available. Should more information become available, this case will be re-assessed and notes will be updated. There is a potential for blood borne pathogen transmission, therefore this event is reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2018-05830 |
| MDR Report Key | 7916816 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-27 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-07-12 |
| Date Added to Maude | 2018-09-27 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal | 75038 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | MENTOR TEXAS |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI-TEC III ASPIRATOR, 110V |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2018-09-27 |
| Catalog Number | PT-ASP-III-110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR TEXAS |
| Manufacturer Address | 3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |