MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for CAST REMOVAL SAW TCC2SAW manufactured by Derma Sciences, Inc..
[105255925]
The device was not yet returned to the manufacturer for analysis. 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
[105255926]
It was reported by the customer that on (b)(6) 2018, when cutting the cast off of a patient, the tcc2saw cast removal saw started to smoke and then stopped working. The customer borrowed a cast saw from an orthopedic doctor office nearby to complete the procedure. No patient injury were reported. Additional information was already requested.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9680091-2018-00014 |
MDR Report Key | 7406543 |
Date Received | 2018-04-09 |
Date of Report | 2018-03-16 |
Date of Event | 2018-03-15 |
Date Mfgr Received | 2018-04-26 |
Date Added to Maude | 2018-04-09 |
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 | 0 |
Brand Name | CAST REMOVAL SAW |
Generic Name | TCC OTHER |
Product Code | LGH |
Date Received | 2018-04-09 |
Catalog Number | TCC2SAW |
Lot Number | 35160 |
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 | 2018-04-09 |