MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-03 for RADIESSE VOICE 8044M0 manufactured by Bioform Medical, Inc..
[21316331]
(b)(6) called merz north america, inc to report that a patient, female was injected at another facility with radiesse voice and is currently in the icu of this hospital with an airway obstruction. He stated that the icu called him 20 minutes ago asking for information about the product and for a reversal of the airway. He stated that he had printed the radiesse voice instructions for use and sent it to the icu. (b)(6) agreed to a medical consult (discussion of the case with a health care professional). On (b)(6) 2014 (b)(6) spoke with dr. (b)(6), a merz contracted physician. Dr. (b)(6) stated that (b)(6) had very very little clinical information about the patient and thus information was very limited and advice and guidance was unable to be provided. Dr (b)(6) provided his contact information for him to provide to the treating physicians in case he/she wanted to contact me. Dr (b)(6) have not heard from anybody else about this incident. On (b)(6) 2014 (b)(6), director of icu was contacted. The patient, female had respiratory distress and was intubated. She is currently on a ventilator and there are no plans to remove the ventilator today. She was not able to provide any information regarding where or when the patient was injected. On (b)(6) 2014 (b)(6), director of icu was contacted. She was asked how the patient is doing. (b)(6) stated that the patient is doing ok. She was then asked when the patient came off the ventilator. (b)(6) said she thinks it was on friday ((b)(6) 2014). She does not have the patient's chart in front of her. She was asked if the patient came into the hospital unconscious. (b)(6) replied that she did not know. Further questions were asked and (b)(6) replied that she does not know as she does not have the patient's chart in front of her.
Patient Sequence No: 1, Text Type: D, B5
[21664416]
Further information has been requested but has not been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135225-2014-00004 |
| MDR Report Key | 3688138 |
| Report Source | 05 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-04 |
| Date of Event | 2014-02-04 |
| Date Mfgr Received | 2014-02-04 |
| Date Added to Maude | 2014-04-18 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN METZ |
| Manufacturer Street | 4133 COURTNEY ROAD SUITE 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 | RADIESSE VOICE |
| Generic Name | INJECTABLE IMPLANT |
| Product Code | KHJ |
| Date Received | 2014-03-03 |
| Catalog Number | 8044M0 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFORM MEDICAL, INC. |
| Manufacturer Address | FRANKSVILLE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-03 |