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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN / SPORTS SURGERY SURGIPRO

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COVIDIEN / SPORTS SURGERY SURGIPRO Back to Search Results
Model Number SPM149
Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Positioning Problem (3009)
Patient Problems Pain (1994); Multiple Organ Failure (3261)
Event Date 08/02/2012
Event Type  Injury  
Event Description

The hernia mesh they put in came loose and rolled up and was so painful. I had to have it removed and when they removed it, my vital organs started shutting down. Had to have dialysis and they are putting glucose in me about every couple hours and was in icu for long time spent about 25 or so days in (b)(6). I did not know if i was going to live or not.

 
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Brand NameSURGIPRO
Type of DeviceSURGIPRO
Manufacturer (Section D)
COVIDIEN / SPORTS SURGERY
MDR Report Key6538042
MDR Text Key74293841
Report NumberMW5069480
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberSPM149
Device Catalogue NumberSPM149
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/28/2017 Patient Sequence Number: 1
Treatment
I HAVE TOO MANY TO LIST.
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