MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-14 for TECHFORM PREMIUM CAST TAPE 204WH manufactured by Bl Tech Co Ltd..
[4094132]
While technician cut cast off patient, the cast removal created dust. The patient inhaled the dust and developed skin rash.
Patient Sequence No: 1, Text Type: D, B5
[11493452]
Patient was provided with a topical steroid. We provided a copy of the msds to the practitioner.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2085446-2014-00001 |
| MDR Report Key | 3597228 |
| Report Source | 05 |
| Date Received | 2014-01-14 |
| Date of Report | 2014-01-14 |
| Date of Event | 2013-11-26 |
| Date Mfgr Received | 2013-12-19 |
| Date Added to Maude | 2014-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DR. |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECHFORM PREMIUM CAST TAPE |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2014-01-14 |
| Model Number | 204WH |
| Catalog Number | 204WH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BL TECH CO LTD. |
| Manufacturer Address | KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-14 |