MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 20CM X 20CM DRESSING - 5 PACK; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802028

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during npwt, the patient experienced an hematoma around the wound and the dressing was covered in blood according to the doctor pico could have injured the patient.The dressing was applied on (b)(6) 2022, because, even though the wound made a very good impression after 3 weeks of therapy, it was not yet closed and some exudate continued to leak out.It is unknown how this has been addressed.Current health status of patient is unknown.

Event Description

It was reported that, during treatment of a pressure ulcer with pico 14, the patient experienced a hematoma around the wound and the dressing was covered in blood.Treatment began on (b)(6) 2021.The dressing was changed on (b)(6) 2022, because even though the wound had made very good progress after 3 weeks of therapy, it was not yet fully closed and some exudate continued to leak out.The wound environment was stated to be perfect with no maceration at the time of the dressing change.On 07jan2022, the reported hematoma and bleeding was observed.It is unknown how this has been addressed.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.The batch records were reviewed and it could be confirmed that the products progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed no similar instances of the reported event.A risk management review concluded that without further information, the alleged harm can not be directly linked to a specific failure mode within the risk file although it contains several failure modes that can result in different severities of bleeding, of which, the worst-case risk level is low.No updates to the risk files are required.A clinical assessment concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Probable root cause may relate to incorrect application of dressing or infrequent dressing changes.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct techniques when applying the dressing and frequency of dressing changes according to the amount of wound exudate.It advises that more frequent dressing changes are required for a moderate to high wound exudate.This investigation is now complete, with no corrective actions required.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.Complaint 2 of 2.Reference case-2022-00088179-1 / mdr 8043484-2022-00031 for related complaint.

• Brand Name: PICO 20CM X 20CM DRESSING - 5 PACK
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13362251
• MDR Text Key: 284633501
• Report Number: 8043484-2022-00030
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111156730
• UDI-Public: 4582111156730
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 66802028
• Device Lot Number: 2051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Date Device Manufactured: 12/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 66802046 / 5112 - PICO 14 15X20CM CTN1
• Patient Outcome(s): Other
• Patient Sex: Female