Brand Name | MINSTREL (INCL. MINERVA) |
Type of Device | NONE |
Manufacturer (Section D) |
ARJOHUNTLEIGH POLSKA SP. Z O.O. |
ul. ks. piotra wawrzyniaka 2 |
komorniki 6205 2 |
PL 62052 |
|
Manufacturer (Section G) |
ARJO, INC. |
50 north gary ave., suite a |
|
roselle IL 60172 168 |
|
Manufacturer Contact |
|
50 north gary ave., suite a |
roselle, IL 60172-1684
|
|
MDR Report Key | 3888115 |
MDR Text Key | 4424880 |
Report Number | 1419652-2014-00142 |
Device Sequence Number | 1 |
Product Code |
FNG
|
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/29/2014,04/30/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | TML 100 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/29/2014 |
Distributor Facility Aware Date | 04/30/2014 |
Device Age | 15 YR |
Event Location |
Nursing Home
|
Date Report to Manufacturer | 05/29/2014 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/30/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 59 YR |
Patient Weight | 95 |
|
|