MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for BLAKE DRAIN UNKNOWN PRODUCT manufactured by Ethicon Inc..
[188004211]
Product complaint # (b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. Procedure name. Procedure date. Date of event? Product code and lot number? The provided code: j1245 and lot: e180820 are not ethicon product/lot, please advise? Was the drain broken during removal after completion of its use? Location and size of the drain piece retained in patient? How was drain secured? Were any anomalies noted of the drain condition upon placement? Did the drain come in contact with sharp objects at any time: surgical instruments, surgical needles, sutures,? Did the drain function as intended? Was the retained piece removed from the patient surgically? Are any plans in place the remove the drain piece in future? Date? Are there any other adverse patient consequences due to this issue and how were they treated? If suction was not completed, was a new drain inserted in the patient? Please provide patient demographic information: age, gender, weight, bmi at the time of the index procedure? What is the current status of the patient? What is the physician? S opinion as to the etiology of or contributing factors of this event? To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[188004212]
It was reported a patient underwent an unknown procedure on an unknown date and a drain was used. On (b)(6) 2020, when trying to remove the drain according to medical prescription, a slight resistance was felt, performed a massage in place, it is evident that the drain left around 10cm from the cavity and had new resistance. The drain removed after traction. It is evidenced that the tip of the catheter was retained inside the lumbar cavity, after requested x-ray of the lumbar region, evidencing that part of the drain is in the lumbar cavity. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01510 |
| MDR Report Key | 9755924 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-26 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEGANIA SILICON LTD.-ISREAL |
| Manufacturer Street | DEGANIA BET |
| Manufacturer City | EMEK HAYARDEN 15130 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 15130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAKE DRAIN UNKNOWN PRODUCT |
| Generic Name | WOUND DRAINAGE SYSTEM |
| Product Code | KOG |
| Date Received | 2020-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |