MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-06-15 for CERVICAL DEPTH GAUGE 387.292 manufactured by Synthes (usa).
[19311421]
Device report from synthes europe reported an event in (b)(6) as follows: it was reported that a surgical procedure was delayed by 15 minutes due to a problem distinguishing between sleeve part numbers 387. 292 and 03. 161. 028, due to part 387. 292 not having the part number etched on it and the potential for mix-up and mismeasurement since both devices are compatible with several depth gauges. There was no report of patient harm. This complaint is alleged against part number 387. 292. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19770819]
Device was used for treatment, not diagnosis. Patient information was not provided by reporter. (b)(6). Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-14478 |
| MDR Report Key | 4845850 |
| Report Source | 01,05,07 |
| Date Received | 2015-06-15 |
| Date of Report | 2015-05-29 |
| Date of Event | 2015-05-29 |
| Date Mfgr Received | 2015-05-29 |
| Date Added to Maude | 2015-07-13 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERVICAL DEPTH GAUGE |
| Generic Name | TAPE, MEASURING, RULERS & CALIPERS |
| Product Code | FTY |
| Date Received | 2015-06-15 |
| Catalog Number | 387.292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-15 |