MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for TPHA SCREEN TEST CELLS 0066826 manufactured by Immucor, Inc..
[76134028]
The immucor review concluded that the probability of occurrence of harm (poh) is improbable (b)(6). The severity of a transfusion transmitted (b)(6) is considered serious because the resulting injury (infection) would require medical attention. This mdr is linked to (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[76134029]
On (b)(6) 2017, immucor deemed an mdr reportable to fda, due thirty (30) days from the date of (b)(6) 2017 for tpha screen test cells (lot number 280006).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2017-00094 |
| MDR Report Key | 6592307 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-05-25 |
| 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 | MR HOWARD YOREK |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 300915625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TPHA SCREEN TEST CELLS |
| Generic Name | FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM |
| Product Code | MYR |
| Date Received | 2017-05-25 |
| Catalog Number | 0066826 |
| Lot Number | 280006 |
| Device Expiration Date | 2017-03-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |