MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-19 for PROFORE 18-25CM ANKLE CIRC. CASE 8 66000016 manufactured by Smith & Nephew Medical Ltd..
[95318502]
Patient Sequence No: 1, Text Type: N, H10
[95318503]
It was reported that the ifu for profore product was misleading. An elderly lady's leg was amputated because profore was applied and the patient had significant arterial problems. Abpi was 0. 9.
Patient Sequence No: 1, Text Type: D, B5
[107028137]
Sample was not evaluated due to there was no sample returned for investigation.
Patient Sequence No: 1, Text Type: N, H10
[109128446]
Patient Sequence No: 1, Text Type: N, H10
[109128447]
It was reported that the patient passed away before the amputation could be performed.
Patient Sequence No: 1, Text Type: D, B5
[109154339]
A complaints history review was carried on the whole profore range and no complaints of a similar nature have been recorded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00314 |
| MDR Report Key | 7130810 |
| Date Received | 2017-12-19 |
| Date of Report | 2018-05-03 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2017-12-19 |
| 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 | MR MARKUS POETTKER |
| Manufacturer Street | SCACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROFORE 18-25CM ANKLE CIRC. CASE 8 |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2017-12-19 |
| Catalog Number | 66000016 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Deathisabilit | 2017-12-19 |