MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-10 for SURGICAL WATER SOLUBLE LUBRICANT * manufactured by *.
[601909]
This occurred in two pts and i have heard from other plastic surgeons that they have had a similar problem. Pts had liposuction and a water soluable jelly is used to lubricate the cannula to minimize friction and heat to the skin. During the period these pts rec'd treatment, the surgery center purchased a generic brand of lubricant, i believe from mckesson. When the generic lubricant was removed and the original was re-instituted, no more cases of this problem occurred. Both pts developed thick granuloma at the liposuction entrance sites that have required surgical excision to correct. I sent one specimen for biopsy and it demonstrated foreign body reaction and granuloma. I personally know of at least two other plastic surgeons who had similar reactions in their pts around the time frame.
Patient Sequence No: 1, Text Type: D, B5
[6075351]
This occurred in two pts and i have heard from other plastic surgeons that they have had a similar problem. Pts had liposuction and a water soluable jelly is used to lubricate the cannula to minimize friction and heat to the skin. During the period these pts rec'd treatment, the surgery center purchased a generic brand of lubricant, i believe from mckesson. When the generic lubricant was removed and the original was re-instituted, no more cases of this problem occurred. Both pts developed thick granuloma at the liposuction entrance sites that have required surgical excision to correct. I sent one specimen for biopsy and it demonstrated foreign body reaction and granuloma. I personally know of at least two other plastic surgeons who had similar reactions in their pts around the time frame.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | MW1042569 |
| MDR Report Key | 838067 |
| Date Received | 2007-04-10 |
| Date of Report | 2007-04-04 |
| Date of Event | 2005-08-01 |
| Date Added to Maude | 2007-04-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL WATER SOLUBLE LUBRICANT |
| Generic Name | * |
| Product Code | KMJ |
| Date Received | 2007-04-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825370 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-04-10 |
| 2 | 0 | 1. Deathisabilit | 2007-04-10 |