MAUDE Adverse Event Report: UNKNOWN PLATE TO ATTACH LEG TO ANKLE; PLATE, FIXATION, BONE

Device Problem Fracture (1260)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Palpitations (2467)

Event Date 08/22/2019

Event Type  Injury  

Event Description

I broke ankle and leg where ankle meets.Plate was put in at (b)(6) hospital in (b)(6).Had stitches 3 weeks but 1 week after stitches removed incision busted open and oozed out.Er did culture inside incision and came back with enterobacter cloacae and (b)(6).I went back into surgery in same hospital.I didn't want to, plus drs aren't trained not to close bacteria or incision for weeks on end, so after 2nd surgery, was advised the plate itself is infected and until removed can't get rid of it yet.All the while, i'm so weak now by this joint my heart sputters at times, scared of that hospital as they had (b)(6) outbreak years ago changing lives forever; and the bone wont heal because bacteria's and cant afford to go daily for iv thru a port for 6 full weeks possibly longer.I don't want another human to go through this excruciating pain.Doctors dont even understand it constantly stings and swells and just wreaks havoc on you altogether.Please stop this deadly spread and educate the public but hold these hospitals responsible for suffering us as they didn't with my surgery to try to wash it out, knowing i had both bacterias.Not one poster, not one face mask, suit and sometimes even gloves were worn at all times 192% mortally and only started with broken bones is one tough reality to face especially when you still care, infected device 6 months later.I only pray i live through it but others should be made aware of these germs just like food establishments are graded, the hospitals should be required to report any diseases caught with inhouse.Any kind that infectious diseases drs either teach these drs about the bacterias or the patient's but you are settling up a death sentence by brushing it under the rug.Save kids, elderly or immunocompromised people by educating them first as well as hospital employees.I pray i do live to be without it but with both don't know my immune system can handle anymore.I do pass don't let it be in vein.Make changes and stop creating false sense of safely and concern/ it can end many lives! i have alot of test results so please contact me and i will gladly send them.Plate still in leg but incision will not totally heal at top until is removed.Was on antibiotics but just too tired to get them and fight drs that didn't even disclose i had it at first.Fda safety report id # (b)(4).

• Brand Name: PLATE TO ATTACH LEG TO ANKLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9824842
• MDR Text Key: 183694852
• Report Number: MW5093710
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 111