| Brand Name | Closed Wound Suction |
| Common Device Name | Wound Drain |
| Manufacturer (Section D) |
| C.R. Bard Inc. (Covington) -1018233 |
| 8195 industrial blvd |
| covington GA 30014 |
|
| Manufacturer (Section G) |
| C.R. Bard Inc. (Covington) -1018233 |
| 8195 industrial blvd |
|
| covington GA 30014 |
|
| Manufacturer Contact |
|
xeeroy
rada
|
| 8195 industrial blvd |
| covington 30014
|
|
+1(770)784-6100
|
|
| MDR Report Key | 50950943 |
| Report Number | 1018233-2026-06223 |
| Device Sequence Number | 10348460 |
| Product Code |
GCY
|
| UDI-Device Identifier | 00801741049354 |
| Combination Product (Y/N) | N |
| Initial Reporter State | FL |
| Initial Reporter Country | US |
| PMA/510(K) Number | Exempt |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Other,Health Professional,User Facility,Company Representative |
| Initial Reporter Occupation |
Physician
|
| Type of Report
| Initial |
| Report Date (Section B) |
09/28/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | 0043610 |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 09/24/2026 |
| Initial Report FDA Received Date | 09/30/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Initial
|
| Patient Sequence Number | 1 |
| Outcome Attributed to Adverse Event |
Other;
|
| Patient Sex | Unknown |
|
|