N
Patient 1
MAUDE MDR 6236244
- MDR report key
- 6236244
- Report number
- 6236244
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-01
- Date received
- 2017-01-10
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TCC EZ CAST | BANDAGE, CAST | DERMA SCIENCES, INC. | ITG | 1115013 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-10 | 0 |
Event Narratives#
D
Patient 1
PATIENT WAS SEEN IN (B)(6) AND CASTED (CAST CALLED TCC EZ). THE PATIENT RETURNED TODAY FOR A FOLLOW UP APPOINTMENT AND HIS RN REPORTED THAT PRIOR TO REMOVAL OF CAST, PATIENT COMPLAINED THE CAST WAS "SOFT." THE PATIENT PROCEEDED TO SAY THAT HE DID NOT CALL TO REPORT IT BECAUSE HE DID NOT WANT TO "BOTHER US." THE CAST WAS REMOVED AND 2 INJURIES/NEW WOUNDS LOCATED TO THE RIGHT LOWER LEG. IT WAS DETERMINED THAT OUR LOT OF CASTS WERE DEFECTIVE. DERMA SCIENCES WAS NOTIFIED IMMEDIATELY AND REMAINING CASTS WERE COLLECTED AND SWAPPED FOR A NEW BATCH. THE MANAGER FROM DERMA SCIENCES WILL BE ISSUING A PRODUCT COMPLAINT REPORT.