MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-14 for NEURX DIAPHRAGM PACING SYSTEM 20-0045 manufactured by Biomedical Inc.
[3971214]
The pt experienced a small amount of yellowish drainage and then crusting at the wire exit site. Mild redness around exit site with blister around most proximal exit site. Event started (b)(6) 2013. Redness increased and was noted on (b)(6) 2013 to have grown approx 4" and firm to the touch, just to the lower right of the exit site. Pt received antibiotics and the event resolved on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005868392-2013-00003 |
| MDR Report Key | 3530483 |
| Report Source | 05 |
| Date Received | 2013-11-14 |
| Date of Report | 2013-11-14 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2013-10-08 |
| Device Manufacturer Date | 2012-10-11 |
| Date Added to Maude | 2014-01-06 |
| 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 | MARK BARBUTES, DIR |
| Manufacturer Street | 300 ARTINO STREET |
| Manufacturer City | OBERLIN OH 44074 |
| Manufacturer Country | US |
| Manufacturer Postal | 44074 |
| Manufacturer Phone | 4402380919 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURX DIAPHRAGM PACING SYSTEM |
| Generic Name | OIR DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPIC |
| Product Code | OIR |
| Date Received | 2013-11-14 |
| Model Number | 20-0045 |
| Lot Number | 20-0045-101012-10-9 |
| Device Expiration Date | 2013-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMEDICAL INC |
| Manufacturer Address | OBERLIN OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-14 |