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Adverse Event Report

B. BRAUN MEDICAL INC. COMFORT-Q SUBCUTANEOUS INJECTION SET   back to search results
Model Number COMFORT-Q
Patient Outcome  Hospitalization;
Event Description

Pt seen in er for local reaction to use of infusion set. Pt reported that infusion set changed on 3/11 and experienced pain. Changed site on 3/12 and noticed original site had approx 1" area of redness and puffiness. Same evening, pt noticed area had become diameter of grapefruit with hard area of 1. 5" x 0. 5". Dr recommended visit to er for evaluation.

 
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Brand NameCOMFORT-Q SUBCUTANEOUS INJECTION SET
Type of DeviceSUBCUTANEOUS INJECTION SET
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 12th ave
po box 4027
bethlehem PA 18018
Device Event Key273016
MDR Report Key282124
Event Key264633
Report NumberMW4002798
Device Sequence Number1
Product CodeFPA
Report Source Voluntary
Report Date 03/14/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberCOMFORT-Q
Device Catalogue Number429000
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 03/29/2000 Patient Sequence Number: 1
#TreatmentTreatment Date
1,1. INSULIN
,
2,2. INSULIN INFUSION PUMP,

Database last updated on January 30, 2009

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