MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-03-14 for POLY C-OMCP-VISUB (H3000) 72238 manufactured by Philips Healthcare.
[1939287]
The customer states that: "the fluoroscopy is no longer possible during exam".
Patient Sequence No: 1, Text Type: D, B5
[9112193]
(b)(4). When investigation is completed, a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3003768277-2011-00250 |
MDR Report Key | 2060884 |
Report Source | 01,07 |
Date Received | 2011-03-14 |
Date of Report | 2011-02-17 |
Date Mfgr Received | 2011-02-17 |
Date Added to Maude | 2011-04-28 |
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 | ANTHONY PERRY |
Manufacturer Street | 595 MINER RD |
Manufacturer City | CLEVELAND OH 44143 |
Manufacturer Country | US |
Manufacturer Postal | 44143 |
Manufacturer Phone | 4404832025 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | POLY C-OMCP-VISUB (H3000) |
Product Code | IZF |
Date Received | 2011-03-14 |
Model Number | 72238 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PHILIPS HEALTHCARE |
Manufacturer Address | VEENPLUIS 4-6 BEST 5680DA NL 5680 DA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2011-03-14 |