MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-08 for MICROMEDICAL 36-SST1250 manufactured by Vyaire Medical.
[126631728]
At this time, the suspect device has not been received by vyaire. If the suspect device is returned an evaluation will be performed and a supplemental report submitted.
Patient Sequence No: 1, Text Type: N, H10
[126631809]
The customer reported that the plastic end piece of mouth guards, used for spirometry, came off in the patient's mouth. The customer was unaware if the patient bit down with their teeth, thus dislodging it. The customer tested other mouth guards and found them to be loose. The customer reported that their was no harm to the patient associated with the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615102-2018-00101 |
| MDR Report Key | 8052942 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-08 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-08 |
| 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 | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | CAREFUSION GERMANY 234 GMBH |
| Manufacturer Street | LEIBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROMEDICAL |
| Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| Product Code | CAH |
| Date Received | 2018-11-08 |
| Model Number | 36-SST1250 |
| Catalog Number | 36-SST1250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-08 |