Brand Name | 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW |
Type of Device | TEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW |
Manufacturer (Section D) |
3M HEALTH CARE |
2510 conway ave |
st. paul MN 55144 |
|
Manufacturer (Section G) |
3M COMPANY BROOKINGS |
601 22nd ave south |
|
brookings SD 57006 |
|
Manufacturer Contact |
dianne
gibbs
|
3m center building 275-5w-06 |
2510 conway ave |
st. paul, MN 55144
|
6517379117
|
|
MDR Report Key | 7655329 |
MDR Text Key | 112909436 |
Report Number | 2110898-2018-00065 |
Device Sequence Number | 1 |
Product Code |
NAD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
07/02/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Nurse
|
Device Model Number | N/A |
Device Catalogue Number | 1668NS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/11/2018 |
Initial Date FDA Received | 07/02/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | HUBER NEEDLE |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 74 YR |