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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT
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TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT Back to Search Results
Catalog Number UNK LINX MAGNETIC IMPLANT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Device remains implanted.
 
Event Description
It was reported that post implant of unknown linx device, on september 6, my mouth became inflamed, very red swollen gums and sore tongue.I consulted with my surgeon after ruling out a virus or bacteria.We decided to do a dilation.After dilation my mouth cleared up.Then within a few weeks it came back.After seeing an ent he said i had reflux at the top of my throat.So back to my surgeon.We did another dilation, the same has happened again.I am 2 weeks from the second dilation and yesterday my mouth has become inflamed and sore again.Linx remains implanted.
 
Manufacturer Narrative
(b)(4).Serious injury.This was omitted on the original report.
 
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Brand Name
UNK LINX MAGNETIC IMPLANT
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4188 lexington avenue north
shoreview MN
MDR Report Key8124337
MDR Text Key129582080
Report Number3008766073-2018-00213
Device Sequence Number1
Product Code LEI
Combination Product (y/n)N
PMA/PMN Number
P100049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK LINX MAGNETIC IMPLANT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/15/2018
Initial Date FDA Received12/03/2018
Supplement Dates Manufacturer Received12/14/2018
Supplement Dates FDA Received12/14/2018
Patient Sequence Number1
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