MAUDE Adverse Event Report: DELTEX MEDICAL LTD DP240; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Device Problem Insufficient Information (3190)

Patient Problem Skin Erosion (2075)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

After follow-up observations, the damage to the patients had recovered.The area was treated with ointment and the scab that had formed has now fallen off.There is no lasting damage to the nasal area which was expected to make a full recovery.Although the deltex medical probe was reported to have been present during the procedure, there is no evidence it was the cause of the scab that formed several days later.No product design or manufacturing issues have been identified.After consultation with representatives from the hospital all parties agree that no further action is required.The device was not found to be the cause of the harm.

Event Description

On 1st november 2016 deltex medical was made aware by a clinician from (b)(6) hospital of a case in which a patient may have developed an area of tissue damage in the region of the outer nose.The extent of the tissue damage was not clear at the time.The procedure was performed on (b)(6), 6 days earlier than the tissue damage was identified.At the time we were uncertain if other devices had also been inserted nasally during the procedure.The potential involvement of a deltex medical doppler probe amongst other equipment was investigated.After follow-up observations, the damage to the patient's nose was found to have recovered.The area was treated with ointment and the scab that had formed fell off.There was no lasting damage to the nasal area which we expect made a full recovery.Although the deltex medical probe was reported to have been present during the procedure, there is no evidence it was the cause of the scab that formed several days later.No product design or manufacturing issues have been identified.After consultation with representatives from the hospital all parties agreed no further action was required since the device did not malfunction, and no harm to the patient was attributed to its use.The device was thrown away at the time of use so no product investigation could take place.

Manufacturer Narrative

Original narrative: after follow-up observations, the damage to the patients nose has been found to have almost completely recovered.The area was treated with ointment and the scab that had formed has now fallen off.There is no lasting damage to the nasal area which is expected to make a full recovery.Although the deltex medical probe was reported to have been present during the procedure, there is no evidence it was the cause of the scab that formed several days later.No product design or manufacturing issues have been identified.After consultation with representatives from the hospital we have been advised that no further action is required.Additional narrative: this report was originally filed by a previous employee who understood in good faith that the file had been sent having received what was thought a receipt.The employee setup the esg portal and this the first time it had been used.There was no other experienced employee at the time that could confirm or deny the file had been correctly sent and received.The receipt was considered confirmation.However, deltex medical ltd contacted fda to query some anomalies on the maude database and found the report had not been received by the correct department.With the employee no longer at the company, deltex medical ltd has had to setup a new portal and had significant difficulty in doing so as is evident from the communications with fda over the past 12 months.The portal has finally been opened in the last 24 hours.This filling is therefore an attempt to correct the fda files and maude database regarding historic reportable incidents in relation to our devices.A further correction should be noted.Prior employees at deltex medical ltd going back 15 years have used an incorrect numbering system for the manufacturer number when reporting 3500a forms into fda.They used the system of cfn # 9680933-yyyy-xxxxx where xxxxx was the cumulative number of incidents without resetting at the start of each calendar year.Hence for example the mfr # 9680933-2006-00003 was in fact only the 3rd incident in history for deltex medical ltd rather than the 3rd incident in 2006.This e3500a submission is now correctly numbered as 9680933-2016-00001 but please be aware the original attempt to file it in 2016 used the manufacturer # 9680933-2016-00011.There had actually only been 11 incidents historically at the time not 11 in the year.

Event Description

[the following script was taken from the original submission] on 1st november 2016 deltex medical was made aware by a clinician from (b)(6) hospital of a case in which a patient may have developed an area of tissue damage in the region of the outer nare.The extent of the tissue damage is not currently known.The procedure was performed on 20th oct, 6 days earlier than the tissue damage was identified.At this time we are uncertain if other devices had also been inserted nasally during the procedure.The potential involvement of a deltex medical doppler probe amongst other equipment is currently under investigation.After follow-up observations, the damage to the patients nose has been found to have almost completely recovered.The area was treated with ointment and the scab that had formed has now fallen off.There is no lasting damage to the nasal area which is expected to make a full recovery.Although the deltex medical probe was reported to have been present during the procedure, there is no evidence it was the cause of the scab that formed several days later.No product design or manufacturing issues have been identified.After consultation with representatives from the hospital we have been advised that no further action is required.

• Brand Name: DP240
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): DELTEX MEDICAL LTD; terminus road; chichester, west sussex PO19 8TX; UK PO19 8TX
• MDR Report Key: 7941319
• MDR Text Key: 123824090
• Report Number: 9680933-2016-00001
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• PMA/PMN Number: K052989
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 121