MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-31 for LARYNGEAL MIRROR SZ 5 OVER LGTH 9-1/4IN RA4700-008 manufactured by Carefusion.
[1890171]
Mirror came off in the back of the patient's throat during a procedure. The mirror was retrieved with forceps and discarded before the incident was reported.
Patient Sequence No: 1, Text Type: D, B5
[8991127]
The instrument was not returned for investigation and the lot number was not provided. Without the lot number, the device history could not be reviewed. Due to not receiving the instrument, this specific occurrence cannot be investigated further. No corrective or preventive action will be initiated at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2011-00003 |
| MDR Report Key | 2035320 |
| Report Source | 05 |
| Date Received | 2011-03-31 |
| Date of Report | 2011-03-31 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-03-11 |
| 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 | 3 |
| 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 |
| Model Number | RA4700-008 |
| Catalog Number | RA4700-008 |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 |