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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CUSTOM NERVE BLOCK TRAY

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B. BRAUN MEDICAL INC. CUSTOM NERVE BLOCK TRAY Back to Search Results
Catalog Number 570245
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Swelling (2091); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn. No adverse quality trends of this nature were identified during the complaint review process for the reported tray catalog number or involved tegaderm material number. If a physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: reports there have been 4 to 5 patients reacting to the tegaderm dressing in the kit. Adductor canal peripheral nerve block catheters were performed for total knee replacements. All the patients expressed sensitivities to the dressing at the same areas in the upper legs. Onset was noted within a couple days of application. The symptoms of sensitivities are under the large tegaderm dressing (6 inch x 8 inch) with severe skin irritation, red inflamed macular papillary, blisters, redness, and/or tenderness. No respiratory sensitivities, distress, or intervention needed. One patient was intravenously treated with benadryl & steroids for blisters. The remaining patients were assessed by surgeons and were reassured that symptoms would go away without any treatment.
 
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Brand NameCUSTOM NERVE BLOCK TRAY
Type of DeviceNERVE BLOCK TRAY
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
Manufacturer Contact
robert hubert
901 marcon blvd.
allentown, PA 18109
6102660500
MDR Report Key5377644
MDR Text Key36338081
Report Number2523676-2015-00696
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number570245
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2016 Patient Sequence Number: 1
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