MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-08-25 for RUSCH STRETCH NECK REBREATH BAG 153000030 manufactured by Teleflex Medical.
[15194487]
The event is reported as: alleged issue: bag is not holding air. When the bag was used, the seal around the neck does not seem to hold the air in the bag. No patient harm reported. Patient current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[15796292]
The device sample was not received by the manufacturer at the time of this report. A follow-up report will be sent when completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2011-00127 |
| MDR Report Key | 2257986 |
| Report Source | 05,06,07 |
| Date Received | 2011-08-25 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-08-10 |
| Date Mfgr Received | 2011-08-16 |
| Date Added to Maude | 2011-11-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | P.O. BOX 28 |
| Manufacturer City | KAMUNTING, PERAK WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH STRETCH NECK REBREATH BAG |
| Generic Name | REBREATH BAG |
| Product Code | BYW |
| Date Received | 2011-08-25 |
| Catalog Number | 153000030 |
| Lot Number | 4226308 |
| Operator | HEALTH PROFESSIONAL |
| 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 | PERAK MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-25 |