MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-03-12 for LINA POWER MORCELLATOR UNKNOWN manufactured by Lina Medical Aps.
[138507380]
Based on description placed in mw5083832 we can conduct that incident wasn't connected with device malfunction. Furthermore device information is not sufficient to be sure that mentioned device was manufacture by lina medical. No further action required.
Patient Sequence No: 1, Text Type: N, H10
[138507381]
Above description was copied from mw5083832 report provided to lina by (b)(6). Lina medical aps haven't been awarded about such event. "the patient underwent power morcellation using the version of this device manufactured by lina during the course of a robotic myomectomy procedure for symptomatic fibroid disease, assumed to be benign. The procedure was performed at (b)(6) hospital in (b)(6). The patient was not informed of the possibility of a uterine soft tissue sarcoma masquerading as a fibroid disease - despite concerning features and clinical symptoms. The patient was not consented for the use of a power morcellator during the myomectomy operation. Within several months, the patient developed extensive abdominal sarcomatosis and in now battling an advanced stage iatrogenic abdominal sarcomatosis. " all information fill in the next steps are also copy from mw5083832 report. Information are not sufficient to conduct what product it was exactly (lack of ref number and batch number)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007699067-2019-00001 |
| MDR Report Key | 8411495 |
| Report Source | OTHER |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-12 |
| 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 | MS MONIKA LEWANDOWSKA |
| Manufacturer Street | FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP, DENMARK DA DK2600, |
| Manufacturer Country | DA |
| Manufacturer Postal | DK2600, |
| Manufacturer G1 | LINA MEDICAL POSKA SP Z O.O. |
| Manufacturer Street | ROLNA 8A SADY |
| Manufacturer City | TARNOWO PODG 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA POWER MORCELLATOR |
| Generic Name | LINA MORCELLATOR |
| Product Code | HET |
| Date Received | 2019-03-12 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 GLOSTRUP, DENMARK DK2600 DA DK2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-12 |