MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-19 for SONIC GENERIC ULTRASOUND TRANSMISSION GEL UNK REF P11111-05 manufactured by Pharmaceutical Innovations, Inc..
[20912132]
Event desc: infection control noted that nicu babies with positive cultures for pseudomonas had all gone for echocardiograms. Investigation lead to culturing the gel. Ultrasound gel comes in 5 liters containers with 8 oz refillable bottles. Bottles are top off and not capped. Eight ounces bottles and 5 liter bottles tested positive for the pseudomonas organism. A new unopened container was sent out for culture - results are pending. Four areas of the hospital use the refillable bottles and rest of the hospital buys the 8 oz bottles. Infection control discourages topping off any fluids. It is not known for sure if the ultrasound gel was the source of the nicu babies infections as is a common organism. Investigation is ongoing. Device usage problem: other.
Patient Sequence No: 1, Text Type: D, B5
[21146475]
Pharmaceutical innovations received a complaint on (b)(4) 2006, from (b)(6) medical center, (b)(4). On (b)(4) 2006, an mdr was received at pharmaceutical innovations from the fda. Pharmaceutical innovations head chemist spoke with (b)(6) at (b)(6) medical center on (b)(4) 2006, and she confirmed the contamination was not from pharmaceutical innovation's gel. The part number and lot number referenced on the mdr was not pharmaceutical innovations, inc. Nomenclature for part number or lot number. The part number p11111-05 is manufactured by joh ali medical, inc. This mdr was never completed and submitted to the fda. The head chemist did not submit the necessary documentation in 2006. As a result of a recent fda inspection this issue was brought to the attention of pharmaceutical innovations, inc. Management and is now being addressed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2241583-2012-00001 |
| MDR Report Key | 2427803 |
| Report Source | 06 |
| Date Received | 2012-01-19 |
| Date of Report | 2006-07-21 |
| Date of Event | 2006-07-21 |
| Report Date | 2006-07-01 |
| Date Reported to FDA | 2006-07-01 |
| Date Mfgr Received | 2006-07-26 |
| Date Added to Maude | 2012-07-30 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GILBERT BUCHALTER |
| Manufacturer Street | 897 FRELINGHUYSEN AVE |
| Manufacturer City | NEWARK NY 071142195 |
| Manufacturer Country | US |
| Manufacturer Postal | 071142195 |
| Manufacturer Phone | 9732422900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONIC GENERIC ULTRASOUND TRANSMISSION GEL |
| Generic Name | GEL, ULTRASOUND |
| Product Code | GYB |
| Date Received | 2012-01-19 |
| Model Number | UNK |
| Catalog Number | REF P11111-05 |
| Lot Number | 122163 |
| ID Number | UNK |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMACEUTICAL INNOVATIONS, INC. |
| Manufacturer Address | 897 FRELINGHUYSEN AVE NEWARK NY 07114219 US 07114 2195 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-01-19 |