MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-06 for ATL CAMERA DRAPE (PRODUCT #2950-1153-01) manufactured by Microtek Medical.
[20430512]
Saline solution leaked out of seam between latex and polyethylene sleeve. Saline dripped into patients chest cavity. Customer claims only a small amout of saline was used and that dripping occurred immediately.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1043582-1998-00004 |
MDR Report Key | 180881 |
Date Received | 1998-08-06 |
Date of Report | 1998-07-14 |
Device Manufacturer Date | 1998-03-01 |
Date Added to Maude | 1998-08-07 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ATL CAMERA DRAPE (PRODUCT #2950-1153-01) |
Generic Name | ULTRA SOUND PROBE DRAPE |
Product Code | KXX |
Date Received | 1998-08-06 |
Returned To Mfg | 1998-07-15 |
Model Number | NA |
Catalog Number | 2950-1153-01 |
Lot Number | D8079R |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 175898 |
Manufacturer | MICROTEK MEDICAL |
Manufacturer Address | 512 LEHMBERG RD. COLUMBUS MS 39702 US |
Baseline Brand Name | ATL CAMERA DRAP (PRODUCT #2950-1153-01) |
Baseline Generic Name | ULTRA SOUND PROBE DRAPE |
Baseline Model No | NA |
Baseline Catalog No | 2950-1153-01 |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1998-08-06 |