MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-05 for Q2 MULTIPORT MANIFOLD EXTENSION LINE 9520 manufactured by Quest Medical, Inc..
[3386814]
Reference: 1649914-2013-00004.
Patient Sequence No: 1, Text Type: D, B5
[10566735]
(b)(4). Device 2 of 5. Quest medical, inc has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported. Quest medical, inc defers to the pt's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2013-00006 |
| MDR Report Key | 2997202 |
| Report Source | 06 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-02-13 |
| Date of Event | 2013-02-13 |
| Date Mfgr Received | 2013-02-13 |
| Date Added to Maude | 2013-05-13 |
| 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 | AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PKWY. |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Q2 MULTIPORT MANIFOLD EXTENSION LINE |
| Generic Name | IV EXTENSION TUBING KITS |
| Product Code | OJA |
| Date Received | 2013-03-05 |
| Model Number | 9520 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ALLEN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-05 |