MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7

Catalog Number UNKN05004902

Device Problem Excessive Heating (4030)

Patient Problems Burn(s) (1757); Rash (2033)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after treatment with pico 7, the patient had a heat rash.It was not reported if there was a backup device or a delay.No other complications were reported.No further information provided.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 no 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 related to procedural technique.A clinical investigation concluded; ¿based on the information provided due to covance, the reported heat rash cannot be confirmed.Per report it is unknown is there was a delay nor if there was a backup device available.Additionally, the impact to the patient beyond the reported heat rash is unknown.Therefore, no further clinical/medical assessment is warranted at this time.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: PICO 7
• Type of Device: PICO 7
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11008297
• MDR Text Key: 221450836
• Report Number: 8043484-2020-04214
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention