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 |