MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for VENTLAB HS34251 manufactured by .
[109052133]
The customer alleges that " the product has holes and tears in the neck of the bag. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2018-00007 |
| MDR Report Key | 7531115 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-21 |
| 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 | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | VENTLAB LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTLAB |
| Generic Name | HYPERINFLATION BAG |
| Product Code | NHK |
| Date Received | 2018-05-21 |
| Returned To Mfg | 2018-05-01 |
| Model Number | HS34251 |
| Lot Number | 307764, 308302 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |