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

Catalog Number UNKN05004900

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Pressure (2994)

Patient Problems Pain (1994); Impaired Healing (2378); Tissue Breakdown (2681); Blister (4537)

Event Date 05/27/2021

Event Type  Injury  

Event Description

It was reported that, during a npwt, after a mastectomy and a breast implant surgery, an unknown pico device kept beeping and afterward was removed from the patient.The patient experienced excruciating pain and a blister developed which was covered with a dressing and has become macerated and very painful.

Event Description

It was reported that, during a npwt started on (b)(6) 2021, after a a mastectomy on both breasts, right one a deconstruction was performed and everything removed and in the left one a nipple sparing surgery and implant inserted.Unknown pico device kept beeping and no healthcare professional was able to reset it or to understand the reason of the alarm.On (b)(6) 2021 the device was removed from the patient and a pressure dressing was applied instead.The patient experienced excruciating pain and a blister developed (noticed on (b)(6) 2021) which was covered with a inadine dressing and has become macerated and very painful, antibiotics and painkillers were prescribed.Tm believed wound complication happened in a different anatomical area to where the dressing was sited and they are unrelated.Patient mentioned that will seek legal advice and sue both the nhs and smith and nephew.The patient had an emergency surgery on 31st july for the debridement and washout of the macerated wound which was previously the big blister.10 days after the surgery, the sutures were removed and the wound started bleeding the following day, so, the patient had to go back to the hospital and have 2 more stitches to stop the bleeding.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include criteria of the wound or user/procedural variance.No lot/serial number has been provided therefore a review of device history is not possible.A complaint history review found further instances of the reported event.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain failure/harm or event.Based on the information provided the clinical root cause of the reported issue could not be concluded.It¿s not clear the relationship of the blister to the pico dressing and if an association exist vs a complication of the procedure and concurrent skin infection.We are unable to rule out a user/procedural variance as a contributing factor to the reported events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.B5: updated description.H6: updated codes.

Event Description

It was reported that, during npwt with an unknown pico device that began on (b)(6) 2021, after a left mastectomy, the device was observed to have no pressure and was beeping on (b)(6) 2021.The patient developed a blister and experienced excruciating pain.The wound became macerated and the patient was treated with antibiotics and analgesics.On (b)(6), 2021, the pico device was removed, and a compression dressing was applied.The patient underwent an emergency surgery on (b)(6), 2021 to debride and washout the macerated wound.Ten days after the surgery, the sutures were removed and the wound started bleeding the following day, so, the patient had to go back to the hospital and have 2 more stitches to stop the bleeding.Current patient status is unknown.

Manufacturer Narrative

H10: updated investigation the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.No lot/serial number has been provided, therefore a review of device history is not possible.A complaint history review found a small number of similar instances in the last 3 years.There is nothing to indicate that this is outside of acceptable rates of occurrence.A clinical assessment concluded that based on the information provided the clinical root cause of the reported issue could not be concluded.It¿s not clear the relationship of the blister to the pico dressing and if an association exist vs a complication of the procedure and concurrent skin infection.The review was unable to rule out a user/procedural variance as a contributing factor to the reported events.A risk management review concluded that there is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.The ifu contains detailed instructions in relation to wound suitability under section 8.1, the application and removal of dressings and use of the pump under section 8.2 it also details contraindications under section 3 and precautions under section 6.Troubleshooting the device warning lights is also covered in section 14 this investigation is now complete with no corrective actions required.Smith + nephew will continue to monitor for any adverse trends relating to this product range.B5: updated description h6: updated codes.

• 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: 12096075
• MDR Text Key: 259273848
• Report Number: 8043484-2021-01624
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ON THE (B)(6) 2021, SHE HAD A MASTECTOMY AND A B; ON (B)(6) 2021, SHE HAD A MASTECTOMY AND A B
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female