MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-12 for TCC-EZ CASTING SYSTEM 3" SINGLE APPLICATION TCC23002 manufactured by Derma Sciences, Inc..
[130498287]
Dhr - no deviations found in the production process or in the finished goods inspection. The products were released without quality issues. Retained samples were pulled out one for analysis. Full specification testing was done and all parameters were found to be acceptable. Appearance is good and no sticky issue was observed. From the investigation, the complaint was not confirmed. Root cause can not be determined as there was no sample received for evaluation and the complaint was not confirmed. However, this problem can occurred due to several factors that affect the performance of the product during the preparation and application, like water temperature, rolling technique, excess water removal, rubbing technique and drying time. With regards to sticky issue, the product must be stored within the indicated 15oc- 30oc. Storage outside the indicated temperature might cause the migration of the resin that result to stickiness.
Patient Sequence No: 1, Text Type: N, H10
[130498288]
2 of 2 reports - other mfg reports number: 9680091-2018-00039. It was reported that the facility is having issues with "sticky" tcc-ez kits that won't harden properly. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00040 |
| MDR Report Key | 8157532 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-12 |
| 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 CASTING SYSTEM 3" SINGLE APPLICATION |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2018-12-12 |
| Catalog Number | TCC23002 |
| Lot Number | 0918021 |
| 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 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |