MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-04 for REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR 04.315.132 manufactured by .
[4046020]
Sales consultant reported that the curvilinear distractor did not performed its intended function. Event did not result in patient harm. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11330426]
Device was used for treatment, not diagnosis. The investigation could not be completed; no conclusion could be drawn, as no product was received. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07305 |
| MDR Report Key | 3498884 |
| Report Source | 05,07 |
| Date Received | 2013-12-04 |
| Date of Report | 2013-10-31 |
| Date of Event | 2013-10-31 |
| Date Mfgr Received | 2013-10-31 |
| Date Added to Maude | 2014-03-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ODESSA MORRIS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR |
| Product Code | MON |
| Date Received | 2013-12-04 |
| Catalog Number | 04.315.132 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-04 |