MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-04 for TCC-EZ UNK manufactured by Derma Sciences.
[4655818]
Add'l info received on (b)(6) 2014: dear dr (b)(6), we are providing add'l info on our investigation into the medwatch report #mw5032582. A preliminary response was sent to your attention on (b)(4) 2014. As initially communicated to you, (b)(6) provided us with limited info on (b)(6) 2014 that he was seen at (b)(6) for a small sore on the ball of his right foot, where he received the derma sciences tcc-ez (total contact cast system). He apparently did not return to that medical center for treatment of an infection that developed, as he was admitted to (b)(6). From there, he was transferred to (b)(6), and surgery was performed by dr (b)(6). After discharge, he was seen by (b)(6), and now he was being seen by the home health nurses from (b)(6). As our initial contact with the hospitals provided us with limited info, we repeatedly contacted the hospitals via certified mail in anticipation of understanding the circumstances surrounding this adverse event report. These letters were mailed to the three hospitals on (b)(6) 2014. Certified mail receipts were received by derma sciences as confirmation of delivery of these letters to the hospitals on (b)(4) 2014. In response to our certified letter, derma sciences clinician (b)(4) was able to speak with personnel in dr (b)(6) office. We were informed that (b)(6) was first seen by dr (b)(6) on (b)(6) and admitted with "cellulitis r lower extremity". Surgery was performed on (b)(6) by dr (b)(6) for "cellulitis and excisional debridement of r lower extremity" including incision and drainage. There was no definitive documentation about the origination of the cellulitis nor any specific reports of a direct relation to (b)(6) explanation of the wound he mentions on the ball of the r foot. F/u visit was (b)(6) with no further visits. There was no documentation at all about (b)(6) being in a tcc or previously being in a tcc nor could dr (b)(6) office offer comment on whether the tcc could have been related to the infection. The tcc was presumably placed prior to any interaction with dr (b)(6) and his office could not find any documentation of casting anywhere in (b)(6) case notes. However, from our previous f/u efforts, we did determine that the cast was applied at (b)(6). (b)(6), who is the clinical director at (b)(6), was hesitant to share any pt info, and also was not very informed specifically about (b)(6) situation. In the opinion of our clinical staff, cellulitis is a fairly common diagnosis, and it is extremely difficult to ascertain the true cause of cellulitis. There is no history of tcc-ez causing any infection or cellulitis in pts, and none of the info received from our investigation has indicated that the cast malfunctioned in any way. Based on the investigation we have performed and the info we have on hand, we do not have any info to suggest that the tcc-ez caused or contributed to the pt's injury. At this point, we consider this investigation to be closed. In the meantime, please do not hesitate to contact me if you require any add'l info.
Patient Sequence No: 1, Text Type: D, B5
[21735085]
I was fitted with a tcc-ez total contact cast system at the wound clinic at (b)(6). Which caused a serious infection of my lower right leg. It requires 13 days of inpatient hospitalization. Surgery and continuing home health care to try and resolve the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032582 |
| MDR Report Key | 3455679 |
| Date Received | 2013-11-04 |
| Date of Report | 2014-04-24 |
| Date of Event | 2013-10-17 |
| Date Added to Maude | 2013-11-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCC-EZ |
| Generic Name | TCC-EZ |
| Product Code | ITG |
| Date Received | 2013-11-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | TOTAL CONTACT CAST SYSTEM |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-11-04 |