Brand Name | 3M¿ MULTIPORE¿ DRY SURGICAL TAPE |
Type of Device | 3M MULTIPORE DRY TAPE |
Manufacturer (Section D) |
3M HEALTH CARE |
2510 conway ave |
st. paul MN 55144 |
|
Manufacturer (Section G) |
3M JAPAN PRODUCT LIMITED |
5500 ooaza-osanagi |
higashine-shi |
yamagata, 999-3 737 |
JA
999-3737
|
|
Manufacturer Contact |
dianne
gibbs
|
3m center, building 275-5w-06 |
2510 conway ave |
st. paul, MN 55144
|
6517379117
|
|
MDR Report Key | 13777393 |
MDR Text Key | 287249119 |
Report Number | 2110898-2022-00024 |
Device Sequence Number | 1 |
Product Code |
KGX
|
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 |
Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/15/2022 |
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 |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 3730-0 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/01/2022 |
Initial Date FDA Received | 03/16/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | NEOBAR® |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 1.5 WK |
Patient Sex | Female |
Patient Weight | 1 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | Black Or African American |