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 2019-07-26 for LMA UNIQUE (SILICONE CUFF) CPV SIZE 4 105200-000040 manufactured by Teleflex Medical.
[152516616]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[152516617]
The customer reported "cuff inflates via syringe prior to use but will not deflate when tested prior to patient use, the correct ifu procedure had been adhered to. ". There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00230 |
| MDR Report Key | 8832189 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-26 |
| Date of Report | 2019-07-04 |
| Date of Event | 2019-07-02 |
| Date Mfgr Received | 2019-08-19 |
| Date Added to Maude | 2019-07-26 |
| 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 | 2019-07-26 |
| Returned To Mfg | 2019-07-30 |
| Catalog Number | 105200-000040 |
| Lot Number | NRAMGC |
| 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 | 2019-07-26 |