MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-06 for COOLTONE APPLICATOR CS-A4-EMS-XX manufactured by Zimmer Medizinsysteme Gmbh.
[182469206]
Based on the information currently available to the device importer, (b)(4) a serious injury possibly caused by use error, has occurred during cooltone treatment. All information obtained thus far was forwarded to the manufacturer, zimmer medizinsysteme (b)(4), which is the responsible party for completing the device investigation, root cause identification and determination if a reportable malfunction has occurred.
Patient Sequence No: 1, Text Type: N, H10
[182469207]
Allergan received a report regarding a patient who sustained an abdominal burn from a metal button on clothing worn during 2-minute treatments to both abdomen and buttocks. Prior to the cooltone treatment, the patient was also treated with a 5-minute session using emsculpt, a non-allergan product. It was stated that the patient? S abdominal treatment area had decreased sensation due to prior abdominoplasty. The burn was diagnosed as 3rd degree and is healing well following debridement and topical antibiotics, corticosteroids, and scar-minimization ointments. The cooltone user manual states that metallic objects should be at least 1. 2 meters away from the device and its accessories during use. Allergan is in contact with the treatment provider in order to obtain additional follow-up information. If additional information is received, the event will be re-assessed, and a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010720-2020-00001 |
| MDR Report Key | 9803064 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-06 |
| 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 | MS. JENNIFER CLETO |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Manufacturer G1 | ZIMMER MEDIZINSYSTEME GMBH |
| Manufacturer Street | JUNKERSSTRASSE 9 |
| Manufacturer City | NEU-ULM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOLTONE APPLICATOR |
| Generic Name | STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING |
| Product Code | NGX |
| Date Received | 2020-03-06 |
| Catalog Number | CS-A4-EMS-XX |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MEDIZINSYSTEME GMBH |
| Manufacturer Address | JUNKERSSTRASSE 9 NEU-ULM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |