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 2020-01-08 for BLAKE (R) DRAIN 15FR R/F 2229 manufactured by Ethicon Inc..
[185899484]
Product complaint # (b)(4). The following additional information was requested, however not received to date: procedure name. Procedure date. Was the drain broken during removal after completion of its use? Location and size of the drain piece retained in patient? Surgeon's opinion about piece of drain left in the patient? 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? Lot number how long was the drain left in place? What is the current condition of the patient? Attempts to obtain additional information and the device have been made with no response to date. 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
[185899485]
It was reported a patient underwent an unknown procedure on an unknown date and a drain was used. After removing the drain, it was noticed that a piece of a drain stayed inside of a patient. No other information is known. No product to be returned. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00217 |
| MDR Report Key | 9567127 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-13 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-08 |
| 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 (R) DRAIN 15FR R/F |
| Generic Name | WOUND DRAINAGE SYSTEM |
| Product Code | KOG |
| Date Received | 2020-01-08 |
| Catalog Number | 2229 |
| 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 | 2020-01-08 |