MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-22 for NATURAL IMAGE ULTRASOUND SCANNING GEL manufactured by Accupac, Inc..
[8807]
Reported info uncovered during a civil trial on 5/12/93 where mfr testified under oath that they were in violation of fda gmp in having "lost" and not replaced from their customer complaint file reports of mold contamination of medical diagnostic ultrasound scanning gels which mfr had mfg for another co. Mfr also testified under oath to not having notified the fda of the missing documents during fda inspections of facility, to having "lost" lab records of the contaminated product, and to having "lost" the actual sample of the contaminated product supplied to mfr by the co that gel is mfg for. When they opened the 40 gallon fiber drums of the ultrasound scanning gel, the surface was covered with mold. Approx 10 to 20% of the 800 8 oz plastic bottles of product had mold at the top. Product was immediately quarantined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000306 |
| MDR Report Key | 11676 |
| Date Received | 1994-02-22 |
| Date of Report | 1993-06-03 |
| Date Added to Maude | 1994-02-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAL IMAGE ULTRASOUND SCANNING GEL |
| Product Code | KNG |
| Date Received | 1994-02-22 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11676 |
| Manufacturer | ACCUPAC, INC. |
| Manufacturer Address | MAINLAND PA 19451 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-22 |