MAUDE Adverse Event Report: COVIDIEN / SPORTS SURGERY SURGIPRO

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.

• Brand Name: SURGIPRO
• Type of Device: SURGIPRO
• Manufacturer (Section D): COVIDIEN / SPORTS SURGERY
• MDR Report Key: 6538042
• MDR Text Key: 74293841
• Report Number: MW5069480
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• 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 Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SPM149
• Device Catalogue Number: SPM149
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: I HAVE TOO MANY TO LIST.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 120