MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-16 for PROLARYN GEL 8602M0K5 manufactured by Merz North America, Inc..
[47502389]
This case was assessed as reportable to the fda as the adverse event, possible allergic reaction requiring intubation, was deemed to meet serious injury criteria of requiring medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. The device history record for radiesse dermal filler lot 100088620 was reviewed. No nonconformances were noted that would have contributed to this event. A lot search was conducted on the reported lot and no similar events were noted.
Patient Sequence No: 1, Text Type: N, H10
[47502390]
A physician reported that a (b)(6) male patient was injected with prolaryn. On (b)(6) 2016, patient was injected with an unspecified amount of prolaryn to an unspecified area. On (b)(6) 2016, patient developed increased breathing, a fever of 102, and voice changes. Treatment reported as intubation. On 24-may-2016, follow up information was received from the physician. Patient had no vocal fold paresis, paralysis, or atrophy. Patient was injected to the interarytenoid space with an unspecified amount of prolaryn gel for dysphagia. On 06-jun-2016, follow up information was received from the physician. Patient was injected with 0. 3ml of prolaryn gel and experienced a possible allergic reaction. On an unspecified date, patient was intubated to protect the airway. Five days later, he was extubated. Medical history positive for chronic dysphagia and aspiration. Concomitant medications and relevant medical history reported as none. Lot number reported as 100088620. Causality reported as possibly related.
Patient Sequence No: 1, Text Type: D, B5
[49802987]
The device history record for prolaryn gel lot 100088620 was reviewed.
Patient Sequence No: 1, Text Type: N, H10
[49802988]
The following information was gathered from medwatch report mw5062519, which was received on 06-jul-2016. The patient developed respiratory distress requiring intubation 24 hours following injection with prolaryn gel to the interarytenoid space. Patient was intubated for four days and eventually extubated without complication. The route of administration was submucous. The indication for use was pharyngeal dysplasia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2016-00015 |
| MDR Report Key | 5728789 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-16 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-05-19 |
| Date Mfgr Received | 2016-07-06 |
| Device Manufacturer Date | 2016-03-15 |
| Date Added to Maude | 2016-06-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOTT SYKES, MD |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH NC 27615 |
| Manufacturer Country | US |
| Manufacturer Postal | 27615 |
| Manufacturer Phone | 9195828000 |
| Manufacturer G1 | MERZ NORTH AMERICA, INC. |
| Manufacturer Street | 4133 COURTNEY ROAD SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLARYN GEL |
| Generic Name | INJECTABLE IMPLANT |
| Product Code | MIX |
| Date Received | 2016-06-16 |
| Catalog Number | 8602M0K5 |
| Lot Number | 100088620 |
| Device Expiration Date | 2017-03-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA, INC. |
| Manufacturer Address | 4133 COURTNEY STREET, SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-16 |