MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for COTTLE SEPTUM ELEVATOR 9IN SS 88-3873 manufactured by Stoerk Gmbh.
[66875343]
(b)(4). This complaint was opened from a report received through the maude report and contains no contact or facility information, so further information is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[66875344]
Maude report states, "cottle elevator used in ent surgery broke during sinus surgery. The surgeon retrieved the broken piece with no harm to the patient. " the device and lot number are not available. No further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2017-00081 |
| MDR Report Key | 6304787 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-06 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-02-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COTTLE SEPTUM ELEVATOR 9IN SS |
| Generic Name | ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | KAD |
| Date Received | 2017-02-06 |
| Model Number | 88-3873 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STOERK GMBH |
| Manufacturer Address | ENGENERSTR. 11 EMMINGEN 78576 GM 78576 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |