MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-20 for GEM 215 manufactured by Luitpold Pharmaceuticals, Inc..
[50821438]
On (b)(6) 2012, additional information was received from the dental provider who did not have the medical record available at the time of the call. This involved a male in the (b)(6) range. Medical history and concomitant medications were not known. The patient had a large anterior defect of tooth #7 requiring bulk tissue in that area of preparation for a bridge. On an unspecified date gem 215 was placed along with a "ct graft" (connective tissue graft) (medra coded off label use). The patient did well for the next 5 days and then swelling developed (area not specified). Antibiotics were prescribed and the patient was followed every 3 days. Approximately 10 days later there was an abscess and the ct graft had sloughed. Two weeks following the procedure, the dental provider requested the patient have a full range of blood work completed. Results, she reported, were "basically normal" with the exception of an elevated glucose level. The patient was not known to have a history of diabetes and was questioned by the dental provider about the abnormal lab value. In follow up the patient reported that he had eaten a donut prior to submitting blood for the lab work. As of (b)(6) 2012, the patient was 4-5 weeks post procedure and reportedly had completely healed. However, the dental provider reported, "the void is twice as large". There has been bone loss and tissue loss. Treatment information was not provided.
Patient Sequence No: 1, Text Type: N, H10
[50821439]
On (b)(6) 2012, a spontaneous report was received by luitpoid pharmaceuticals inc. Via the adf line from a dental provider involving gem 215. The dental provider stated she had an adverse surgical outcome with gem 215. No additional information was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2410375-2012-00002 |
| MDR Report Key | 2754659 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-09-18 |
| Date Mfgr Received | 2012-06-30 |
| Date Added to Maude | 2012-09-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | P.O. BOX 9001 |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319244000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GEM 215 |
| Generic Name | NONE |
| Product Code | NPZ |
| Date Received | 2012-09-20 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUITPOLD PHARMACEUTICALS, INC. |
| Manufacturer Address | ONE LUITPOLD DR. P.O. BOX 9001 SHIRLEY NY 11967 US 11967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-20 |