MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for AQUACAST SAW STOP AND AQUA CAST SS30 manufactured by Aquacast Liner Llc.
[116992967]
Pt presented for aqua cast removal. An aqua cast with 4 wrap and gore-tex aqua liner with saw stop protective strip were applied at initial cast application. During cast removal, the saw stop liner did not stop the saw blade from contacting the pt's skin. It remains unk if too much pressure was applied to the saw blade during cast removal, and questions remain if the saw stop strip functioned as intended during this case. The pt sustained a 2. 5 full thickness laceration to the left lateral malleolus which required surgical repair. The product was not expired at the time of application or removal, the tech doing removal was up to date on training and competency at time of the event with experience removing pediatric casts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079042 |
| MDR Report Key | 7772611 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-24 |
| Date Added to Maude | 2018-08-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AQUACAST SAW STOP AND AQUA CAST |
| Generic Name | COMPONENT CAST |
| Product Code | LGF |
| Date Received | 2018-08-09 |
| Model Number | SS30 |
| Lot Number | 9D7387_91F010416E |
| Device Expiration Date | 2019-11-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AQUACAST LINER LLC |
| Manufacturer Address | NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-09 |