MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for AUSTIN DENTAL RETR BLADE 3X1/4IN 2-BLUNT MO390 manufactured by Carefusion, Inc.
[75521952]
(b)(4). On 08may2017 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[75521953]
It was reported via email: after retracting we took the austin out and one of the teeth was broken off of the austin retractor. Issue occurred during patient use, no patient harm. On 08may2017 additional information: the austin was in use of a surgery when it was broken. The patient was not hurt because of its malfunction. The patient left stable. The metal point of the retractor was found and taken out of the patient's mouth. We were extracting teeth 1, 16, 17, and 32. No future treatment was needed. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1923569-2017-00046 |
| MDR Report Key | 6573086 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-05-05 |
| Date Mfgr Received | 2017-07-28 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-05-17 |
| 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 | CAREFUSION, INC |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AUSTIN DENTAL RETR BLADE 3X1/4IN 2-BLUNT |
| Generic Name | RETRACTOR, ENT |
| Product Code | KAL |
| Date Received | 2017-05-17 |
| Returned To Mfg | 2017-05-22 |
| Model Number | MO390 |
| Lot Number | A17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-05-17 |