MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-16 for LUBE JELLY MDS032290 manufactured by Medline Industries, Inc..
[3609056]
It was reported that five pts developed infections post operatively. A root cause was not determined but use of the lube jelly was common to all five procedures.
Patient Sequence No: 1, Text Type: D, B5
[11014061]
Five pts developed what was described as atypical infections 4-6 weeks post operatively following breast augmentation procedures. The pts were placed on antibiotic therapy and the implants were subsequently removed. The facility conducted an investigation in an attempt to identify a root cause. All procedures were performed by the same surgeon. There were no other similar infections involving other surgeons at the facility. Unlike the procedures performed by the other surgeons, a unique element to these five pts was the use of the lube jelly on the sizers. The product labeling indicates it is intended for medical purposes for lubricating body orifices to facilitate the entry of diagnostic or therapeutic devices. The actual lube jelly tubes used in the procedures were previously discarded and are not available for eval. The facility had an independent lab conduct testing of breast tissue from one pt and also from a tube of lube jelly they believe to be from the same lot as those involved in the incidents. The breast tissue samples came back positive for the presence of mycobacterium ssp. The lube jelly was negative for the presence of mycobacterium ssp. The facility indicated that a root cause has not been determined but did identify the use of the lube jelly as unique element to these procedures. We have had no other similar incidents reported to us for this device. We have not concluded that the lube jelly was a cause or contributing factor to the adverse events but in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00062 |
| MDR Report Key | 3299473 |
| Report Source | 05,06 |
| Date Received | 2013-08-16 |
| Date of Report | 2013-08-07 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-07-12 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2013-08-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUBE JELLY |
| Product Code | KMJ |
| Date Received | 2013-08-16 |
| Catalog Number | MDS032290 |
| Lot Number | 886808 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-08-16 |