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 2018-05-11 for TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT TCC23001 manufactured by Derma Sciences, Inc..
[108161518]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information. Other mgf report numbers: 9680091-2018-00017.
Patient Sequence No: 1, Text Type: N, H10
[108161519]
2 of 2 reports: it was reported that on (b)(6) 2018, tcc23001 tcc-ez case of 10 casting systems 3" no boot was applied on a patient but did not set up correctly or harden up. Multiple cast was applied on the patient until they found one that hardened. The product problem caused a ten minute delay in the procedure. However, the delay had no impact to the patient's condition or outcome besides the additional time in the clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00016 |
| MDR Report Key | 7509392 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-11 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-05-22 |
| Date Added to Maude | 2018-05-11 |
| 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 | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | DERMA SCIENCES, INC. |
| Manufacturer Street | 104 SHORTING ROAD |
| Manufacturer City | TORONTO, ONTARIO M1S 3S4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M1S 3S4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2018-05-11 |
| Catalog Number | TCC23001 |
| Lot Number | 1017011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES, INC. |
| Manufacturer Address | 104 SHORTING ROAD 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-11 |