TRUEplus TRUEplus 5 bevel Pen Needle 31G/5mm - 100ct boxRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00021292010775), received between May 27, 2020 and Mar 17, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “No Flow” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Failure to Align; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER ADVISED THAT THE PEN NEEDLES ARE NOT ALIGNING WITH HIS HUMALOG KWIK PEN AND THAT WHEN THE PEN NEEDLE DOES WORK, SOMETIMES THE INSULIN IS NOT ASPIRATING. PER CUSTOMER THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PEN NEEDLES SINCE (B)(6) 2026. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621527 ↗
• MalfunctionFeb 17, 2026No Flow

  CONSUMER REPORTED INACCURATE DISPENSE COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE INSULIN DOES NOT GET DISPENSED FROM THE PEN NEEDLE. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR LESS THAN A MONTH. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. CUSTOMER STATED SHE WOULD CONTACT THE PHARMACY FOR THE CORRECT PEN NEEDLES FOR HER PEN INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365067 ↗
• MalfunctionFeb 5, 2026Product Quality Problem; Difficult to Remove; Failure to Align

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES NOT ALIGNING WITH COMPATIBLE PEN NEEDLE INJECTOR. CUSTOMER STATED THAT THE PEN NEEDLE WAS NOT ALIGNING AND WAS GETTING STUCK WHEN ATTEMPTING TO REMOVE. CUSTOMER ALSO REPORTED THAT THE NEEDLES "FEEL LIKE NAILS." COMPLAINT WAS REPORTED BY E-MAIL AND CONTACT MADE WITH CUSTOMER VIA TELEPHONE. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 MONTH. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268374 ↗
• MalfunctionJan 22, 2026No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED WHEN HE NEEDS TO ADMINISTER THE MEDICATION THE PEN NEEDLES WILL NOT ASPIRATE THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. PER THE CUSTOMER HE STARTED USING THE PRODUCT ON (B)(6) 2025. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147598 ↗
• InjuryMay 29, 2025Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. COMPLAINT WAS REPORTED VIA E-MAIL. CUSTOMER STATED IN E-MAIL THAT ON "NO LESS THAN" 18 OF THE PEN NEEDLES THE LOWER HALF OF THE NEEDLE WAS EITHER PARTIALLY OR COMPLETELY MISSING. CUSTOMER STATED THAT ON (B)(6) 2025 SHE HAD EXPERIENCED THIS ISSUE WITH 3 PEN NEEDLES IN A ROW AND HAD NOT BEEN ABLE TO ADMINISTER HER INSULIN. CUSTOMER STATED SHE HAD GONE TO THE HOSPITAL EMERGENCY DEPARTMENT AND RECEIVED IV FLUIDS AND FAST ACTING INSULIN VIA IV. CUSTOMER STATED THAT IF SHE HAD NOT CHECKED HER PEN NEEDLES, SHE "COULD HAVE DIED THAT EVENING OF DIABETIC KETOACIDOSIS." CUSTOMER STATED THAT SINCE THEN SHE HAS FOUND AN ADDITIONAL 15 PEN NEEDLES FROM THE SAME LOT THAT ARE "DEFECTIVE." MANUFACTURER ATTEMPTED TO CONTACT CUSTOMER VIA E-MAIL AND TELEPHONE CALL IN EFFORT TO OBTAIN ADDITIONAL INFORMATION AND ASSIST WITH THE INITIAL CONCERN; MANUFACTURER WAS UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

  Patient problems: Hyperglycemia; Insufficient Information

  MAUDE report 22104420 ↗
• MalfunctionJul 15, 2024Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES WERE BENT. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER IS UNSURE HOW LONG THEY HAVE BEEN USING THE PRODUCT. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. CUSTOMER DOES NOT HAVE ANY MORE PEN NEEDLES LEFT IN THE BOX. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741810 ↗
• MalfunctionFeb 22, 2024Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. WIFE/CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT SOME OF THE PEN NEEDLES WERE BENT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER COULD NOT RECALL THE PURCHASE DATE. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757170 ↗
• MalfunctionNov 22, 2023Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT WHEN THE PLASTIC COVER IS REMOVED FROM THE PEN NEEDLE, SOMETIMES THE PROTECTIVE CAP THAT COVERS THE NEEDLE FALLS OFF BY ITSELF AND THE NEEDLE IS SOMETIMES BENT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT ONE WEEK. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191067 ↗
• MalfunctionJul 10, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES DID NOT ASPIRATE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. THE CUSTOMER NEEDS THE PRODUCT REPLACED IMMEDIATELY DUE TO NOT BEING ABLE TO GET HER INSULIN. THE CUSTOMER STATED THAT SHE IS UNABLE TO GET ANOTHER SUPPLY AT THIS TIME. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287831 ↗
• MalfunctionJun 6, 2023Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT WHEN THE PROTECTIVE COVER FROM THE 31G PEN NEEDLES IS REMOVED, THE NEEDLES ARE BENT. CUSTOMER DID NOT DISCLOSE HOW LONG HE HAS BEEN USING THE PEN NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072882 ↗
• MalfunctionApr 6, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE 31G PEN NEEDLES WERE NOT ASPIRATING. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER FROM THE PHARMACY. CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR ONE MONTH. THE CUSTOMER IS SUING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689344 ↗
• MalfunctionApr 6, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLES WERE NOT PUSHING THE INSULIN THROUGH. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THIS PARTICULAR BOX OF PEN NEEDLES FOR A LITTLE OVER A MONTH. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED, AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688709 ↗
• MalfunctionFeb 28, 2023Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE 31G PEN NEEDLES ARE BENT. CUSTOMER STATED THE NEEDLES ARE BENT PRIOR TO ATTACHING TO THE PEN INJECTOR. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAS BEEN USING THE PEN NEEDLES OUT OF THIS PACKAGE FOR ONE WEEK. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. CUSTOMER STATED THAT THE INCOMPATIBLE PRODUCT IS NOT THE ISSUE, AS IF THE NEEDLES ARE NOT BENT THEY WORK AS INTENDED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451642 ↗
• MalfunctionFeb 10, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. CONSUMER REPORTED COMPLAINT THE 31G PEN NEEDLES DID NOT DISPENSE THE INSULIN. HUSBAND STATED THAT CUSTOMER IS WASTING INSULIN DUE TO THIS ISSUE. CUSTOMER HAD PURCHASED TWO BOXES, SAME LOT NUMBER; THE SECOND BOX IS UNOPENED. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16357622 ↗
• MalfunctionDec 14, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE OF TRUE PLUS PEN NEEDLES. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER STATES THAT HIS GLUCOSE NUMBERS WENT UP HIGH AND HE IS NOT SURE WHY. CUSTOMER STATES THAT THE ONLY THING THAT CHANGE WAS THE NEW PEN NEEDLES HE IS USING. CUSTOMER BELIEVES THE BOX OF PEN NEEDLES THAT HE OPENS UP WAS NOT GIVING HIM ENOUGH INSULIN AND THAT CAUSE HIS BLOOD SUGAR TO GO UP HIGHER. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF INACCURATE DISPENSE OF PEN NEEDLES. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER STATES THAT HE OPENS UP A NEW BOX OF PEN NEEDLES AND EVERYTHING IS BACK TO NORMAL HIS BLOOD SUGAR IS BACK TO NORMAL. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2026 AND OPEN VIAL DATE IS 1 WEEK AGO.

  Patient problems: Hyperglycemia

  MAUDE report 15982680 ↗
• InjuryJun 21, 2022Break; Break

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT THE PEN NEEDLE HAD BROKEN OFF AND WAS STUCK IN HER STOMACH. CUSTOMER HAD BEEN UNABLE TO CONTINUE WITH THE CALL AS SHE HAD CONTACTED 911. CUSTOMER WAS CONTACTED THE FOLLOWING DAY, (B)(6) 2022 AND STATED THAT SHE HAD BEEN TAKEN TO THE HOSPITAL THE DAY BEFORE WHERE THEY HAD ATTEMPTED TO REMOVE THE NEEDLE FROM HER STOMACH BUT WERE NOT SUCCESSFUL. CUSTOMER HAD BEEN DISCHARGED AND WAS ADVISED TO APPLY WARM/HOT COMPRESS TO THE AREA TO SEE IF THE NEEDLE WILL WORK ITSELF OUT OF THE SKIN. CUSTOMER STATED THAT SHE WAS REFERRED TO A SURGEON BY THE HOSPITAL BUT SHE HAS NOT YET CONTACTED THEM, AS SHE IS ON HER WAY TO SEE HER DOCTOR FOR A ROUTINE SCHEDULED APPOINTMENT AND WILL SHOW HER DOCTOR AND OBTAIN FEEDBACK. CUSTOMER STATED THAT AT THE PRESENT TIME, THE AREA IS RED AND SLIGHTLY SWOLLEN.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 14753761 ↗
• MalfunctionApr 13, 2022Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION AND BENT NEEDLE FOR THE 31G TRUEPLUS PEN NEEDLES. CUSTOMER STATED THAT WHEN SHE USED THE PEN NEEDLES SHE WAS NOT ABLE TO DRAW UP THE AMOUNT OF INSULIN NEEDED AND THAT THE INSULIN "OOZED" OUT AND WOULD NOT FLOW THROUGH THE PEN NEEDLE. CUSTOMER ALSO STATED THAT THE NEEDLES WERE BENT AND UNABLE TO BE USED. CUSTOMER STATED THAT SHE HAS WASTED ABOUT DOZEN AND A HALF OF THE PEN NEEDLES. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103114 ↗
• MalfunctionDec 14, 2021No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ ASPIRATION OF THE 31G PEN NEEDLES. CUSTOMER WAS CONCERNED THE PEN NEEDLES ARE UNABLE TO ADMINISTER HER INSULIN BECAUSE OF NOT ASPIRATING / INACCURATE DISPENSE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS WAS NOT THE FIRST TIME THE CUSTOMER USED THE PRODUCT OUT OF THIS PACKAGE; CUSTOMER HAS BEEN USING SINCE (B)(6) 2021. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS PROPERLY ALIGNED. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM THEY WERE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003626 ↗
• MalfunctionJul 21, 2020No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR PEN NEEDLES NOT ACCURATELY DISPENSING INSULIN. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE PEN NEEDLE LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2023 AND OPEN VIAL DATE IS A FEW WEEKS AGO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301715 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT THAT WHEN SHE USES THE PEN NEEDLES AND ATTEMPTS TO INJECT HER INSULIN, SHE GETS A BURNING SENSATION. CUSTOMER DID NOT NEED MEDICAL INTERVENTION RELATED TO THE USE OF THE PEN NEEDLES. CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT THREE MONTHS. THE PACKAGE HAD NOT BEEN OPENED OR DAMAGED WHEN RECEIVED BY CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DECLINED TO RETURN ANY OF THE PEN NEEDLES FOR INVESTIGATION.

  Patient problems: Burning Sensation

  MAUDE report 10093991 ↗