MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-03-31 for LARYNGEAL MIRROR SZ 5 OVER LGTH 9-1/4IN RA4700-008 manufactured by Carefusion.
[1888758]
The mirror fell? Off into the patient's throat? During the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8997758]
The result of this investigation is not complete at this time. Once the analysis of the sample associated with the occurrence is completed, if applicable, a corrective and preventive action will be initiated. A follow-up report will be submitted to you with this information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2011-00002 |
| MDR Report Key | 2035287 |
| Report Source | 05,07 |
| Date Received | 2011-03-31 |
| Date of Report | 2011-03-30 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-03-01 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2011-04-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARYNGEAL MIRROR SZ 5 OVER LGTH 9-1/4IN |
| Generic Name | MIRROR |
| Product Code | KAI |
| Date Received | 2011-03-31 |
| Returned To Mfg | 2011-03-15 |
| Model Number | RA4700-008 |
| Catalog Number | RA4700-008 |
| Lot Number | M01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-31 |