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Adverse Event Report

3M CO. TEGADERM STERILE TRANSPARENT DRESSING   back to search results
Patient Outcome  Hospitalization;
Event Description

On 5/13/99, pt discharged from hosp with tegaderm sterile transparent dressing in place over picc site insertion. The picc was placed on 5/7/99. In pm on 5/13, nurse (rn) visited to do tpn teaching, and noted skin under tegaderm "only with diffuse redness, inflammation and tenderness". Tegaderm removed and opsite 3000 placed, as pt has latex and some adhesive tape allergy. On 5/14, rn visited when pt c/o continuous pain at picc site while tpn infusing. Nurse noted increased area of inflammation: redness, heat, firmness, and swelling. Picc line discontinued per dr order. On 5/15/99, pt admitted to hosp for cellulitis and clot in picc line arm.

 
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Brand NameTEGADERM
Type of DeviceSTERILE TRANSPARENT DRESSING
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
3M CO.
3m center, bldg 275-3e-08
st paul MN 55133 3275
Device Event Key218236
MDR Report Key225059
Event Key211219
Report NumberMW1016374
Device Sequence Number1
Product CodeFRO
Report Source Voluntary
Report Date 05/24/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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