MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-11-29 for MINSTREL (INCL. MINERVA) manufactured by Arjohuntleigh Polska Sp. Zo.o..
[21728422]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21920697]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2013-00063 |
| MDR Report Key | 3573250 |
| Report Source | 05,06,07 |
| Date Received | 2013-11-29 |
| Date Mfgr Received | 2013-10-31 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2014-01-15 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE KAHN |
| Manufacturer Street | 2349 WEST LAKE ST. KOMORNIKI |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 8003231245 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINSTREL (INCL. MINERVA) |
| Generic Name | NONE |
| Product Code | JFT |
| Date Received | 2013-11-29 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-29 |