MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for GIBSON-COOKE SWEAT TEST APPARATUS IPS-25A manufactured by C & S Electronics, Inc..
[41620589]
Patient Sequence No: 1, Text Type: N, H10
[41620590]
Following routine sweat chloride testing with the quantitative pilocarpine iontophoresis procedure using the gibson cooke sweat test apparatus, dark spots on left lower arm were noted after the test was complete and gauze was removed. Six months later, patient presents with persistent skin changes and apparent scarring of the region. A thorough investigation of the reagents, equipment, procedure, staff, training, and competency was performed and no specific cause could be identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5540657 |
| MDR Report Key | 5540657 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-29 |
| Date of Event | 2015-07-09 |
| Report Date | 2016-03-29 |
| Date Reported to FDA | 2016-03-29 |
| Date Reported to Mfgr | 2016-03-29 |
| Date Added to Maude | 2016-04-01 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIBSON-COOKE SWEAT TEST APPARATUS |
| Generic Name | DEVICE, IONTOPHORESIS, SPECIFIC USES |
| Product Code | KNM |
| Date Received | 2016-04-01 |
| Model Number | IPS-25A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 23 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C & S ELECTRONICS, INC. |
| Manufacturer Address | 2565 16TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-01 |