MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for MCKESSON SURGICAL LUBRICANT 16-8946 manufactured by Unk.
[113512847]
I have previously ordered and used a surgical lubricant mckesson mr #119-8946 - this is a 5 gram packet. It is a good product and it is made in the usa. My supplier substituted mckesson mfr #16-8946 which is made in (b)(4) and it is of very poor quality. Note that the last four digits of these two products are the same. It is the first 2-3 digits that are different. Three of the ingredients in the good product are not in the bad product. There is a phenomena called wetability that can be measured to determine how well something spreads. I am guessing that one of the ingredients in the good product enhances the wetability. It spreads very smoothly whereas the (b)(4) product beads up into little clumps. The (b)(4) product is unsuitable as a surgical lubricant for use in intermittent catheterization. This is not the fault of my supplier because they let me know that the usa product is no longer available. Mckesson medical-surgical inc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078277 |
| MDR Report Key | 7665758 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-07-02 |
| Date Added to Maude | 2018-07-06 |
| 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 | 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 | 0 |
| Brand Name | MCKESSON SURGICAL LUBRICANT |
| Generic Name | LUBRICANT, PATIENT |
| Product Code | KMJ |
| Date Received | 2018-07-05 |
| Model Number | 16-8946 |
| Lot Number | CHB11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |