MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-25 for LMA CLASSIC LARYNGEAL MASK, SIZE 5 10150 manufactured by The Laryngeal Mask Co Pte Ltd..
[21764332]
The event is reported as: the blue inflation balloon burst. No pt injury/harm.
Patient Sequence No: 1, Text Type: D, B5
[21894114]
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681900-2013-00002 |
| MDR Report Key | 3023083 |
| Report Source | 06 |
| Date Received | 2013-02-25 |
| Date of Report | 2013-02-04 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2013-02-05 |
| Date Added to Maude | 2013-05-03 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | THE LARYNGEAL MASK CO PTE LTD. |
| Manufacturer Street | 16 JALAN KILANG #04-01 HOI HUP BLDG |
| Manufacturer City | SINGAPORE 159416 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 159416 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA CLASSIC LARYNGEAL MASK, SIZE 5 |
| Generic Name | LARYNGEAL MASK AIRWAY |
| Product Code | BSJ |
| Date Received | 2013-02-25 |
| Returned To Mfg | 2013-02-12 |
| Catalog Number | 10150 |
| Lot Number | 8YNAEL5N |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE LARYNGEAL MASK CO PTE LTD. |
| Manufacturer Address | 16 JAAN KILANG #04-01 HOI HUP BLDG SINGAPORE 159416 SN 159416 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-25 |