MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-19 for PROLARYN PLUS manufactured by Merz North America.
[15378489]
In the emergency room pt had a ct scan which showed a nodular mass in the supraglottic area, suggesting possible calcium deposit. There was edema around the mass. This was above the injection site. The pt had no airway problem, but his main trouble was that he couldn't "get anything down. " because he couldn't get anything down, he was admitted to the hosp and put on iv steroids and antibiotics. By (b)(6) 2015, he was swallowing enough so that he could go home. Physician called pt on (b)(6) 2015 and he was doing okay. The device history record could not be conducted as the lot number was not reported.
Patient Sequence No: 1, Text Type: N, H10
[15383136]
Physician injected pt with prolaryn plus for left vocal cord paralysis on (b)(6) 2015. He injected 0. 7 cc to the left vocal cord and the remainder of the syringe to the right vocal cord. Two days later pt went to the emergency room complaining of difficulty swallowing, throat pain, and a low grade fever.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2015-00041 |
| MDR Report Key | 4860157 |
| Report Source | 05,07 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-05-21 |
| Date Added to Maude | 2015-06-23 |
| 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 | T WATSON |
| Manufacturer Street | 4133 COURTNEY ROAD, #10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal | 53126 |
| Manufacturer Phone | 2628353300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLARYN PLUS |
| Product Code | KHJ |
| Date Received | 2015-06-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA |
| Manufacturer Address | FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-06-19 |