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 |