MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for PREMIERPRO 8807 manufactured by Sunmed Holdings Llc..
[119946872]
The customer alleges that "pressure infusion bags are not holding pressure once inflated. " affected product was returned. Visual inspection and functional testing was performed on the affected product and no issues with the product have been identified.
Patient Sequence No: 1, Text Type: N, H10
[119946873]
The customer alleges that "pressure infusion bags are not holding pressure once inflated. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2018-00028 |
| MDR Report Key | 7868191 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-08-13 |
| Date Added to Maude | 2018-09-12 |
| 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. NW. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | SUNMED HOLDINGS LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW 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 | 3 |
| Brand Name | PREMIERPRO |
| Generic Name | PRESSURE INFUSION BAG |
| Product Code | KZD |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-08-27 |
| Model Number | 8807 |
| Lot Number | 180400282 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED HOLDINGS LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. NW SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |