MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-06 for MI PASTE PLUS 002888 manufactured by Gc Corp..
[3811272]
Patient had an alleged reaction to product. Patient's hygienist used mi paste as prophy paste during cleaning appointment for this new patient to their practice. Patient's history had listed numerous allergens. Patient's mother just listed food allergy and was not specific that it was severe allergy to all dairy products. Other known allergies listed were peanuts and (b)(4). As soon as the hygienist started to polish patient's teeth he stopped her after he noticed his mouth was tingling and swelling. He asked her what was in the product and she had to go check. Patient could feel swelling on lips, throat and tongue and immediately started rinsing mouth. Hygienist started to read off what was in the product and came across benzoate allergies and milk protein allergies contraindication and patient then called for his mother to bring in epi pen that was immediately administered in the office by his mother. Patient said he is allergic to all dairy products. Dentist never had a chance to evaluate his patient, the mother immediately took him to the hospital where he was treated in e. R. For an allergic reaction. Patient was administered benadryl 100mg and a prednisone drip to counteract reaction. Patient was first admitted to icu since he is a sleep apnea patient and has lung development issues to watch his oxygen levels. He was released the next morning after reaction subsided and will follow up with his primary physician (b)(6) on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[11289875]
No samples received from dentist. Evaluation based on phone interview. Mi paste and mi paste plus warning statement being reviewed and revised.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1410097-2013-00003 |
| MDR Report Key | 3346749 |
| Report Source | 05 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-08-20 |
| Date Facility Aware | 2013-08-20 |
| Report Date | 2013-09-03 |
| Date Reported to FDA | 2013-09-03 |
| Date Added to Maude | 2013-09-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3737 WEST 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer Phone | 7089263090 |
| Manufacturer G1 | GC CORP. |
| Manufacturer Street | 76-1 HASUMUNA-CHO, ITABASHI-KU |
| Manufacturer City | TOKYO 174 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MI PASTE PLUS |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2013-09-06 |
| Catalog Number | 002888 |
| Lot Number | 120106V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORP. |
| Manufacturer Address | 76-1 HASUNUMA-CHO, ITABASHI-KU TOKYO 174 JA 174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-09-06 |