MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-29 for KERRAPRO KPRO30 manufactured by Crawford Healthcare Ltd.
[140285805]
The ward manager and matron identified suspected deep tissue injuries had possibly increased in the last month. They suggested the only change that had been made was the increased use of kerrapro and both patients were documented as having kerrapro heels in place at time of pressure damage being identified. The ward have identified sdti to heels prior to this where kerrapro is not in use, however this was a theory highlighted by the ward manager and matron when hospital acquired pressure damage was identified in quick succession. Use of the normal offloading foam boots had been discontinued by the ward and an increase in use of kerrapro has been identified over the last month. Discussions of appropriate use of the product with staff on the ward and other wards identified that staff on the ward where the incident occured were not as confident in the products use or when to remove/check device placement. Ward staff stated the issue they identified was maceration of skin, which may be suggestive of not removing as appropriate. As staff on this ward were unclear of when they would check the device during the day it may suggest pressure damage was caused by slippage of the device and pressure occurring on this area. No other wards have reported similar concerns. Currently kerrapro is still being used; however, removed from the ward.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004051837-2019-00003 |
| MDR Report Key | 8463663 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2017-06-14 |
| Date Facility Aware | 2017-06-14 |
| Report Date | 2017-06-14 |
| Date Reported to Mfgr | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2019-03-29 |
| 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 ANDREW JACKSON |
| Manufacturer Street | KING EDWARD COURT KING EDWARD ROAD |
| Manufacturer City | WA160BE |
| Manufacturer Country | UK |
| Manufacturer Postal | WA16 0BE |
| Manufacturer G1 | PRIM S.A. |
| Manufacturer Street | AVDA. CONSTITUCION, P-221 P.I. MONTE BOYAL |
| Manufacturer City | CASARRUBIOS DEL MONTE TOLEDO, E-45950 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | E-45950 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRAPRO |
| Generic Name | KERRAPRO HEEL |
| Product Code | FMP |
| Date Received | 2019-03-29 |
| Model Number | KPRO30 |
| Catalog Number | KPRO30 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRAWFORD HEALTHCARE LTD |
| Manufacturer Address | KING EDWARD COURT KING EDWARD ROAD KNUTSFORD, WA160BE UK WA16 0BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |