MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-08 for CITRIZYME 15250 manufactured by Pascal Co., Inc..
[2542199]
The patient was given our powdered product, citrizyme, a class i medical device enzymatic ultrasonic cleanser, mixed in a glass of water by the dentist to drink. Package labeling for citrizyme clearly states "not for human consumption. " according to the dentist's office, it is a standard practice to administer to the patient a prepared solution of vitamin c to drink. The dentist mistook a packet of citrizyme for the packet of vitamin c. Patient contacted our office for information about this product. We informed the patient of the contents, and to seek medical attention. After several attempts to contact the patient, we finally spoke to her on (b)(6) 2011. She confirmed she went to the er and they "ran a few blood tests" and contacted poison control. Poison control reported to the hospital that no preventative measures needed to be taken with citrizyme. The patient complained of "flu like" symptoms for a few days following ingestion, but feels fine now. (03/03/2012, please note: this is a resubmission of this report to correct mfr report#).
Patient Sequence No: 1, Text Type: D, B5
[9729969]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011632-2011-00001 |
| MDR Report Key | 2491124 |
| Report Source | 05 |
| Date Received | 2012-03-08 |
| Date of Report | 2011-05-09 |
| Date of Event | 2011-04-14 |
| Date Mfgr Received | 2011-04-14 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-07-30 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT TENTARELLI |
| Manufacturer Street | 2929 N.E. NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal | 98004 |
| Manufacturer Phone | 4256023633 |
| Manufacturer G1 | PASCAL CO., INC. |
| Manufacturer Street | 2929 N.E. NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CITRIZYME |
| Generic Name | ULTRASONIC CLEANER (88.06150) (FLG) |
| Product Code | MDZ |
| Date Received | 2012-03-08 |
| Model Number | 15250 |
| Catalog Number | 15250 |
| Lot Number | 090612 |
| ID Number | NA |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PASCAL CO., INC. |
| Manufacturer Address | BELLEVUE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-08 |