MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-06 for DP240 manufactured by Deltex Medical Ltd.
[123824090]
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.
Patient Sequence No: 1, Text Type: N, H10
[123824091]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680933-2016-00001 |
| MDR Report Key | 7941319 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-06 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-11-01 |
| Date Added to Maude | 2018-10-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR GRAHAM LOWE |
| Manufacturer Street | TERMINUS ROAD |
| Manufacturer City | CHICHESTER, WEST SUSSEX PO198TX |
| Manufacturer Country | UK |
| Manufacturer Postal | PO19 8TX |
| Manufacturer G1 | DELTEX MEDICAL LTD |
| Manufacturer Street | TERMINUS ROAD |
| Manufacturer City | CHICHESTER, WEST SUSSEX PO198TX |
| Manufacturer Country | UK |
| Manufacturer Postal Code | PO19 8TX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DP240 |
| Generic Name | PROBE, BLOOD-FLOW, EXTRAVASCULAR |
| Product Code | DPT |
| Date Received | 2018-10-06 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DELTEX MEDICAL LTD |
| Manufacturer Address | TERMINUS ROAD CHICHESTER, WEST SUSSEX PO198TX UK PO19 8TX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-06 |