MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-05 for HOUGH STAPED FOOT PLATE PICK STRTIP 90DG AU20790 manufactured by Carefusion, Inc.
[76832557]
(b)(4): supplier lot identified upon receipt of complaint device as lot xfax04 on (b)(6) 2017. Instrument supplier notified of the reported complaint. After sample decontamination the device forwarded to supplier (b)(6) 2017. Supplier confirmed receipt of mdr complaint notification (b)(6) 2017. A supplier evaluation of the device is anticipated but has not yet completed to date. A follow up mdr submission will be completed upon receipt of device evaluation by manufacturer or if any additional information is provided for the issue by the customer.
Patient Sequence No: 1, Text Type: N, H10
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Medical specialties - broken; the sales rep reported via email that the instrument broke during a case on (b)(6) 2017. The instrument broke inside a patient and the broken piece could not be retrieved due to potential risk of hearing loss upon removal. Additional information was provided (b)(6) 2017: the instrument piece has not been retrieved to date. The procedure being performed when the instrument was being used broke was a stapedectomy. The retained object is the tip of instrument. The object has not been retrieved to date. An x-ray was not taken, the physician is confident the piece retained in the patient and is so small could not be picked up with imaging. The procedure was completed as planned. The patient condition is currently unknown. On (b)(6) 2017: instrument returned and supplier identified. Production lot xfax04 physically confirmed. Supplier has been notified of the complaint. Device evaluation by supplier anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2017-00088 |
| MDR Report Key | 6613319 |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-04-18 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-05 |
| 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 | 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 | AVALIGN GERMAN SPECIALTY INSTRUMENTS DIVISION |
| Manufacturer Street | 626 COOPER COURT |
| Manufacturer City | SCHAUMBURG IL 60173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOUGH STAPED FOOT PLATE PICK STRTIP 90DG |
| Generic Name | STAPEDECTOMY FOOT PLATE PICK |
| Product Code | JYT |
| Date Received | 2017-06-05 |
| Returned To Mfg | 2017-05-10 |
| Model Number | AU20790 |
| Lot Number | XFAX04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-05 |