STERI STRIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-25 for STERI STRIP manufactured by 3m.

Event Text Entries

[1611230] Reaction to steri strips. One year ago, i had surgery at (b)(6) in (b)(6) performed by (b)(6). The surgery was for an av fistula to prepare for dialysis. After waiting over 6 months for what they call a "thrill" we decided the surgery was a failure. Please don't misunderstand me: fistulas fail, and i get it. But i believe the reaction to the surgical tapes made this delicate surgery fail for me. Before surgery, i made sure he knew i was allergic to adhesives. Bandaids, ekg pads, steri-strips: i have had similar reactions to all 3. Ekg pads leave swollen red itchy circles on my skin for weeks after the test. When i woke up from surgery, there were what i called "steri strips" or tape closures on the incision on my left wrist. I found a nurse and told her i was worried about the tape, and also about a bruise on the back of my right hand. She had no advice for either thing. The next day, the skin under the tapes was red and raised and swollen, but it didn't itch yet. I called (b)(6) and they told me to come in. I drove back down to (b)(6) from my home in (b)(6) - less than 60 miles, but over an hour in (b)(6) traffic-. Dr (b)(6) was not in, and i do not recall the name of the doctor who saw me. He looked at it, but really didn't say much. However, it did start itching within a day or so. It was obvious that the swelling was directly related to the tape. To this day, there is still redness exactly where there were tapes. I did try neosporin a few days later, and found out i am allergic to that too. I knew i was allergic to penicillin. Eventually, the tapes did come off. I had the same reaction to the tapes when i had a hernia operation a few years before at (b)(6), but the difference was the tapes were single pieces at the small laparoscopic incisions, not right next to each other. Since i had to repeat the surgery, i got worried about the tapes this year and complained to 3m. (b)(4) from 3m called me and checked with dr (b)(6) who does not agree with me that the reaction caused the fistula to fail. The av fistula surgery was just done on the vein in my upper arm this past (b)(6) 2010, at a different facility, cyanoacrylate -super glue- used to close incision, no redness, swelling or itching. "thrill" felt within days, bruit heard by md. Success! I called 3m; they checked with md; i believe it was steri strips. Dates of use: (b)(6) 2009 - (b)(6) 2009. Diagnosis or reason for use: surgery incision closure. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5016533
MDR Report Key1743013
Date Received2010-06-25
Date of Report2010-06-25
Date of Event2009-06-24
Date Added to Maude2010-07-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTERI STRIP
Generic NameSTERI STRIPS
Product CodeFPX
Date Received2010-06-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
Manufacturer3M
Manufacturer AddressMN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-06-25

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