MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for HOUSE STRUT FORCEP FINE SMTH JAW 3-1/8IN AU15300 manufactured by Carefusion, Inc.
[78298007]
(b)(4) on 02jun2017 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
[78298008]
Sales rep reported via email: back hung broke. Patient involvement unknown. On 12jun2016 additional information: what was the procedure that was being performed? Yes. Did any part the instrument fall into the patient? S body, and if so how was it retrieved? No. Was there a medical procedure performed to verify if the instrument was in the patient? S body, such as an x-ray? Yes. What was the patient? S outcome? Great. Was the procedure completed as planned? Yes. Can you please send all parts of the instrument for evaluation? Yes. Do you have the lot#? No. On 14jun2017 additional information: what type surgery was being performed? Myringotomy tubes. Please clarify if pieces of the instrument fell inside the patient? S body requiring retrieval. No, nothing fell in pt. If no part of the instrument fell inside patient, why was an x-ray performed? Just in case. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2017-00090 |
| MDR Report Key | 6659849 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2017-06-22 |
| 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 | 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 | HOUSE STRUT FORCEP FINE SMTH JAW 3-1/8IN |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2017-06-22 |
| Model Number | AU15300 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-06-22 |