FDA.reportPublic FDA data

MAUDE MDR 2090151

MDR report key
2090151
Report number
2110898-2011-00048
Event key
0
Event type
3
Date of event
2011-03-08
Date received
2011-05-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACEY STRAND
Address
3M CENTER, BLDG 275-5W-06 ST. PAUL MN 55144 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13M STERI-STRIP SKIN CLOSURES (REINFORCED)880.5240 MEDICAL ADHESIVE TAPE & BANDAGE3M HEALTH CAREFPXNAR1547UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-0601. O

Event Narratives#

D

Patient 1

A SURGICAL MATERIAL SERVICES PROFESSIONAL AT (B)(6) IN (B)(6) CONTACTED (B)(6) TO REPORT BLISTERING ASSOCIATED WITH MASTISOL LIQUID ADHESIVE. THE REPORTER INDICATED THAT THERE WERE FOUR PTS THAT HAD EXPERIENCED BLISTERING FOLLOWING THE USE OF MASTISOL LIQUID ADHESIVE AND STERI-STRIPS. THE SKIN REACTIONS ARE BEING IDENTIFIED DURING THE PTS' POST-OP VISITS UPON REMOVAL OF THE STERI-STRIPS. THE POST-OP VISITS TYPICALLY OCCUR BETWEEN 2 - 7 DAYS, FOLLOWING A SURGERY. THE SKIN REACTION OF BLISTERING ON THE INCISION SITES, FOR THE PT IN THIS COMPLAINT, OCCURRED POST A LAP CHOLE PROCEDURE. THIS PT WAS TREATED WITH TRIAMCINOLONE. ADDITIONAL MEDICAL DATE: (B)(6) 2011 (INFO THAT MADE THIS COMPLAINT REPORTABLE WAS NOT PROVIDED TO 3M UNTIL (B)(6) 2011).

N

Patient 1

METHOD: (TESTING NOT PERFORMED). RESULTS: (PRODUCT NOT RETURNED). CONCLUSIONS: (NO EVALUATION WILL BE PERFORMED).