MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-19 for PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 FGT-20 manufactured by Tornier Inc..
[4921523]
Possible allergy to the implant has appointment with the allergist on thursday (b)(6) 2014. Needs a sample or portion of the silicon and titanium of product that is in the fgt implant. Post op symptom: she came out of the surgery in pain (morphine was administered in the recovery room). Then pain and swelling in her foot. Swelling has reached all joints. Within 4 months of surgery, the downward progression started. Has had numerous tests done for ra, lupus, diabetes, etc. And they have all been negative.
Patient Sequence No: 1, Text Type: D, B5
[12207314]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3004983210-2014-00018 |
MDR Report Key | 4131197 |
Report Source | 04 |
Date Received | 2014-08-19 |
Date of Report | 2014-07-22 |
Date Mfgr Received | 2014-07-22 |
Date Added to Maude | 2014-10-01 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | KEVIN SMITH |
Manufacturer Street | 10801 NESBITT AVE SOUTH |
Manufacturer City | BLOOMINGTON MN 55437 |
Manufacturer Country | US |
Manufacturer Postal | 55437 |
Manufacturer Phone | 9524267643 |
Manufacturer G1 | TORNIER INC. |
Manufacturer Street | 10801 NESBITT AVE SOUTH |
Manufacturer City | BLOOMINGTON MN 55437 |
Manufacturer Country | US |
Manufacturer Postal Code | 55437 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 |
Generic Name | NONE |
Product Code | KWH |
Date Received | 2014-08-19 |
Catalog Number | FGT-20 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TORNIER INC. |
Manufacturer Address | BLOOMINGTON MN US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-08-19 |