MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-08 for SWEAT INDUCER 3700-SYS NA manufactured by Wescor, Inc..
[17826952]
Pt had a repeat sweat chloride test performed on his left arm. When the negative electrode was removed a dime-sized reddened area with a 1mm burn in the center was noted. The disc under the negative electrode was pulling away at the edges and was cracked. Pt was evaluated by a md and the site was described as a 1mm diameter 2nd degree burn with an approx depth of 0. 5mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32681 |
| MDR Report Key | 32681 |
| Date Received | 1996-02-08 |
| Date of Report | 1995-08-14 |
| Date of Event | 1995-08-04 |
| Date Facility Aware | 1995-08-04 |
| Report Date | 1995-08-14 |
| Date Reported to Mfgr | 1995-08-16 |
| Date Added to Maude | 1996-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWEAT INDUCER |
| Generic Name | SWEAT INDUCER |
| Product Code | KTB |
| Date Received | 1996-02-08 |
| Model Number | 3700-SYS |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 33961 |
| Manufacturer | WESCOR, INC. |
| Manufacturer Address | 459 SOUTH MAIN ST LOGAN UT 84321 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-02-08 |