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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE #2 STANDARD; BANDAGE ELASTIC

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SMITH & NEPHEW MEDICAL LTD. PROFORE #2 STANDARD; BANDAGE ELASTIC Back to Search Results
Model Number 66801262
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 05/26/2015
Event Type  Injury  
Event Description
It was reported that the patient developed a severe allergic reaction after being bandaged over the last 6 weeks.Based on the limited information available to smith & nephew at this time, this event is deemed to be a serious injury pursuant to 21 c.F.R.Part 803.3.
 
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Brand Name
PROFORE #2 STANDARD
Type of Device
BANDAGE ELASTIC
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2BN
UK  HU3 2BN
Manufacturer (Section G)
LOHMAN & RAUSCHER GMBH
johann schorch-gasse 4
postfach 222
vienna
AU  
Manufacturer Contact
terry mcmahon
970 lake carillon drive
saint petersburg, FL 33716
MDR Report Key4931165
MDR Text Key6013423
Report Number8043484-2015-00224
Device Sequence Number1
Product Code FQM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number66801262
Device Catalogue Number66801262
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/29/2015
Initial Date FDA Received07/22/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
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