MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-02 for FS19 manufactured by Torax Medical, Inc..
[140689018]
(b)(4). The dhr for lot 3742 was reviewed. No ncs, defects, or reworks related to the product complaint were found.
Patient Sequence No: 1, Text Type: N, H10
[140689019]
It was reported that after a fenix implant procedure in 2014, the patient inadvertently went into an mri machine. Device came apart at the suture and demagnetized. No longer functional so was removed. It is unknown if the case was completed with another device. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2019-00309 |
| MDR Report Key | 8475777 |
| Report Source | FOREIGN |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-11-22 |
| Device Manufacturer Date | 2012-07-16 |
| Date Added to Maude | 2019-04-02 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN |
| Manufacturer Phone | 6107428552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FS19 |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2019-04-02 |
| Returned To Mfg | 2019-04-01 |
| Catalog Number | FS19 |
| Lot Number | 3742 |
| Device Expiration Date | 2016-07-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE NORTH SHOREVIEW MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |