MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for TOTAL CONTACT CAST NOT PROVIDED manufactured by Derma Sciences Inc..
[93078498]
We were notified on august 17, 2017 that during the application of the cast, the cast got hot and caused secondary burn on the leg. Further follow up was made with this hospital as part of our investigation and it was noted that this hospital inspite of all the training had a practise of folding the cast at the calf (they should not be folded at the calf). This increased the layers of the cast around the calf resulting in more exorthermic heat being released which resulted in the burn on the leg. We believe this is what caused the burn on the leg and now the hospital has been advised not to fold at the calf, additional training is being scheduled with the hospital to reinforce correct application of the total contact cast. The patient's ulcer wound healed however a new wound was created by the burn which required additional treatment. Report is late due to sign up process.
Patient Sequence No: 1, Text Type: N, H10
[93078499]
Cast caused secondary burn - resin got too hot caused burn on leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2017-00001 |
| MDR Report Key | 7026084 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-08-17 |
| Report Date | 2017-08-17 |
| Date Reported to Mfgr | 2017-08-17 |
| Date Added to Maude | 2017-11-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOTAL CONTACT CAST |
| Generic Name | TTC-EZ |
| Product Code | ITG |
| Date Received | 2017-11-13 |
| Model Number | NOT PROVIDED |
| Catalog Number | NOT PROVIDED |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES INC. |
| Manufacturer Address | 104 SHORTING ROAD SCARBOROUGH, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-13 |