MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-05-23 for LMA SU FASTRACH COMBO, SITE 5 135250 manufactured by Teleflex Medical Asia Pte Lt.
[3458409]
The event is reported as: the customer reports that the lma device had been inserted into a pt and the balloon "popped" within 15 minutes while the pt was coughing. No report of a pt injury.
Patient Sequence No: 1, Text Type: D, B5
[10793162]
The device sample was discarded by the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681900-2013-00010 |
| MDR Report Key | 3134111 |
| Report Source | 06,07 |
| Date Received | 2013-05-23 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2013-05-09 |
| Date Added to Maude | 2013-06-04 |
| 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 | TELEFLEX MEDICAL ASIA PTE LTD |
| Manufacturer Street | 6 BATTERY ROAD, #07-02 |
| Manufacturer City | SINGAPORE 049909 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 049909 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA SU FASTRACH COMBO, SITE 5 |
| Generic Name | LARYNGEAL MASK AIRWAY |
| Product Code | BSJ |
| Date Received | 2013-05-23 |
| Catalog Number | 135250 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL ASIA PTE LT |
| Manufacturer Address | 6 BATTERY ROAD, #07-02 SINGAPORE 049909 SN 049909 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-23 |