MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT TCC23001 manufactured by Derma Sciences, Inc..
[97475810]
To date the device involved in the reported incident has not been received for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[97475811]
Two of 2 reports: other mfg report number - 9680091-2018-00001. The nurse reported that within (b)(6) 2017, the clinicians combined two boxes of tcc23001 tcc-ez 10 casting systems with different lot numbers (0517037 and 0417014) and was used on two patients. After several days, the patient's cast collapsed and caused rubbing and pressure on the patients? Skin. Which lead to blisters and partial-thickness wounds on the dorsal and lateral foot or ankle of the patients. Standard wound care was done to treat these injuries. Since two boxes of casts were combined and used, the customer was unsure which cast caused the reported injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2018-00002 |
| MDR Report Key | 7197416 |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-19 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-01-16 |
| 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 SONIA IRIZARRY |
| 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 | 0 |
| Brand Name | TCC-EZ CASE OF 10 CASTING SYSTEMS 3" NO BOOT |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2018-01-16 |
| Catalog Number | TCC23001 |
| Lot Number | 0417014 |
| 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 | 1. Other | 2018-01-16 |