MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-16 for HUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER 5372 manufactured by Teleflex Medical.
[5716995]
The customer alleges that the mask had a failed seal when it was used by the staff for resuscitation of a patient.
Patient Sequence No: 1, Text Type: D, B5
[13235146]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2015-00151 |
| MDR Report Key | 4701818 |
| Report Source | 06,07 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-03-21 |
| Date Mfgr Received | 2010-03-23 |
| Date Added to Maude | 2015-06-02 |
| 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, REG. AFFAIRS |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD. |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER |
| Product Code | NHK |
| Date Received | 2015-04-16 |
| Catalog Number | 5372 |
| Lot Number | 0243 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-16 |