MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for T-COAT MICRO HDL KERR RONG THIN 8IN 1MM NL4252-81T manufactured by Carefusion, Inc.
[109374230]
(b)(4) on (b)(4) 2018 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
[109374231]
Via phone conversation: jaw has broken. Additional information received via email on (b)(6) 2018: the date of use was actually 2 different dates. One was on tuesday (b)(6) 2018, and the other on (b)(6) 2018. The kerrisons did break while we were using them in patient? S necks. There was luckily no harm to the patient or the doctor. Both of the kerrisons that we recently ordered have broken. Lot numbers- c17xme and l17xme. On (b)(6) 2018 additional information: patient information: (age, gender, weight) one male, (b)(6), bmi 34. One female, (b)(6), bmi 30. Was there any patient medical intervention? No. What was the patient? S medical status after the event? Stable. Did any part of the device break/fall into the patient? S body field? Yes, the broken piece of the jaw fell into the neck. If yes how was the object retrieved? With the suction and forceps. Did the patient require an additional medical procedure such as an x-ray? No. How was the event resolved, was the device removed from use and replaced with another? Kerrisons were removed from our sets, and now we have two sets down that are incomplete. What type of procedure was being performed? They were both acdf's. Was the procedure completed as planned? Yes. Has your facility reported the event to the fda? No. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00007 |
| MDR Report Key | 7529583 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-21 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW 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 | T-COAT MICRO HDL KERR RONG THIN 8IN 1MM |
| Generic Name | KERRISON RONGEURS |
| Product Code | HAE |
| Date Received | 2018-05-21 |
| Catalog Number | NL4252-81T |
| Lot Number | C17XME |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-21 |