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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE Back to Search Results
Catalog Number 831365
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Injection Site Reaction (4562); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Manufacturer Narrative
When initial trend analysis for lot numbers 52087, 50845, and 52494 was conducted this was the only complaint recorded.Further investigation will be conducted for root cause of complaint.
 
Event Description
A dentist office that also services their patients with botox injections reports that the syringes purchased are different in appearance than in past purchases, such as the cannula is longer and thicker.The office had eight boxes total of lot numbers; lot 52087 expiration date 6/20/2025, lot 52494 expiration date 8/12/2025 and lot 50845 expiration date 11/9/2024.The syringes from the box that were opened, lot 50845, were causing patients bruising, bumps and tenderness at botox injection site.During follow up communication with the dental office which provides several photos of the comparison syringes, the dental office prefers a different brand of syringes.In conclusion, the dental office did not prefer this brand of syringes and there was a mixup with their distributor.The difference in syringe appearance is not a labeling deficiency.
 
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Brand Name
EASYTOUCH
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
MDR Report Key11749142
MDR Text Key280465515
Report Number3005798905-2021-03004
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Notification
Type of Report Initial
Report Date 04/28/2021
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 Number831365
Initial Date Manufacturer Received 04/15/2021
Initial Date FDA Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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