MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-09-27 for GEM 21S manufactured by .
[15019195]
On (b)(6) 2012, a spontaneous report was received by luitpold pharmaceuticals, inc. Involving gem 21s and an unspecified pt. During f/u to a previously reported adverse reaction involving gem 21s ((b)(4)), a dental provider reported a second hand account that her colleague stated he had a pt who had experienced "symptoms similar to flesh eating bacteria" ((b)(6) coded: bacterial infection nos). She stated her colleague used gem 21s off label with this pt ((b)(6) coded: off label use). No additional info was available at the time of this report. Additional info received (b)(6) 2012 from reporting (non-treating) dental provider: after multiple requests to the reporter for the name and contact info of treating dentist, the reporter responded that she would not be providing the requested info, citing "doctor to doctor confidentiality," and stated that "my colleague assured me that he spoke with your company. " no additional info was provided, and on the basis of this response, additional info was not expected for this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2410375-2012-00003 |
| MDR Report Key | 2855517 |
| Report Source | 00,05 |
| Date Received | 2012-09-27 |
| Date of Report | 2012-09-25 |
| Date Mfgr Received | 2012-09-19 |
| Date Added to Maude | 2012-12-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O. BOX 9001 |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319244000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM 21S |
| Generic Name | NONE |
| Product Code | NPZ |
| Date Received | 2012-09-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-27 |