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 Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Chu luan nguyen, nirmal dayaratna, alexander peter comerford, sze ki melanie tam, steven ronald paredes, neshanth easwaralingam, jue li seah, farhad azimi, cindy mak, carlo pulitano, sanjay kumar warrier.Cost-effectiveness of indocyanine green angiography in postmastectomy breast reconstruction.Journal of plastic, reconstructive & aesthetic surgery.Volume 75, issue 9, 2022.Pages 3014-3021.Issn 1748-6815.Https://doi.Org/10.1016/j.Bjps.2022.04.050.

Event Description

It was reported that on literature review "cost-effectiveness of indocyanine green angiography in postmastectomy breast reconstruction", 19 patients treated postoperative with a pico device from a postmastectomy breast reconstruction experienced wound dehiscence.From those 19 patients: (10) patients with indocyanine green angiography technique in implant-based breast reconstruction and (9) patients without indocyanine green angiography technique in implant-based breast reconstruction.It is unknown how patients were treated.Patient's outcome is unknown.No further information is available.

Manufacturer Narrative

This case was reported following a literature review, no product was expected to be returned.A documentation review was performed.Manufacturing records could not be performed, no product identifier was provided.Complaint history records details a number of cases of this nature, with no open or closed escalations within the scope of this report.The instruction for use "ifu" reveals no contributory factors and requires no update.The risk management documentation for pico has been reviewed, to assess whether the alleged failure and associated foreseeable harms have been anticipated.Medical review concluded, all surgical incisions with primary closure are at risk for dehiscence.Risk factors apply, including location and type of surgery besides patient factors and closing method.Therefore, it cannot be concluded that this adverse event was associated with a mal performance of the s&n pico device.

• 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
• 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: 17890085
• MDR Text Key: 325142215
• Report Number: 8043484-2023-00077
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKN05004900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other