MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-03 for MIC-KEY* G-20 LAPAROSCOPIC INTRODUCER KIT 10226 991010226 manufactured by Halyard Health.
[63733490]
(b)(4). The actual complaint product was not returned for evaluation. A review of the device history record is not possible as a lot number was not provided. Root cause cannot be determined. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63733491]
It was reported that a patient had a procedure to place a mic-key feeding tube. On (b)(6) 2016 the patient picked at the scab wound and alleged that a small piece of metal came from the scab area. Additional information was received on 20-dec-2016 from the halyard representative who was present during the patient's procedure on (b)(6) 2016. The halyard representative states the procedure was done laparoscopy and the t-fasteners were placed correctly, and the t-fasteners were not tight. The physician completed the procedure with the correct technique. The were no issues or concerns with the procedure that lasted approximately ten minutes. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[67577666]
Additional information, halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint comp-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67577667]
Additional information received on (b)(6) 2017 that states, a patient got an x-ray last week found some other metals and the patient will have another procedure to remove the metals. No additional information provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611594-2016-00185 |
| MDR Report Key | 6218374 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-03 |
| Date of Report | 2017-01-09 |
| Date of Event | 2016-12-09 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-01-03 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT SA DE R.L. DE C.V. |
| Manufacturer Street | CIRCUITO INDUSTIAL NO. 40 COLONIA OBRERA |
| Manufacturer City | NOGALES, CP |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIC-KEY* G-20 LAPAROSCOPIC INTRODUCER KIT |
| Generic Name | DIGESTHEALTH ENTERAL FEED PERC PLACEMENT |
| Product Code | KCG |
| Date Received | 2017-01-03 |
| Model Number | 10226 |
| Catalog Number | 991010226 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-03 |