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 2019-08-20 for LMA UNIQUE (SILICONE CUFF) CPV SIZE 4 105200-000040 manufactured by Teleflex Medical.
[155057822]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[155057823]
The complaint is reported as: "the valve broke on the product and would not inflate or deflate back down. " no patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00256 |
| MDR Report Key | 8912660 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-20 |
| Date of Report | 2019-08-02 |
| Date of Event | 2019-07-30 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2019-08-20 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA UNIQUE (SILICONE CUFF) CPV SIZE 4 |
| Generic Name | LMA UNIQUE |
| Product Code | CAE |
| Date Received | 2019-08-20 |
| Returned To Mfg | 2019-09-11 |
| Catalog Number | 105200-000040 |
| Lot Number | NRAH2B |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |