MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PICO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number UNKN05004900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a tkr procedure, the surgeon was unaware to put the dressing on 30 degrees flexed, for this reason, the dressing was put on extended as but it was not long enough to cover the incision.As a result, a hematoma formation on the patient was noted.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.The device was not returned for analysis.The reported issue may be linked to application or maintenance techniques.A clinical investigation concluded; based on the information provided by the regional sales manager, the surgeon reported being unaware the dressing should be applied on the patient at 30 degrees flexed, for this reason, the dressing was put on extended.However, according to the surgeon¿s statement, ¿it was not long enough to cover the incision, resulting in a hematoma formation on the patient".The patient¿s outcome is unknown.Per communications, the nurse involved, the nurse educator and ot num will ensure in-services for the proper placement of the pico.Based on the information provided, there is no evidence that supports the smith and nephew device failed.Therefore, no further clinical/medical investigation is warranted at this time.The instructions for use provides comprehensive instructions of the operation, use and limitations of the device.The associated risk file contains the reported event.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN PICO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10945100
• MDR Text Key: 219478296
• Report Number: 8043484-2020-04062
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention