MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-20 for COLLAGEN PLUG-HELIPLUG 62-202 manufactured by Integra York, Pa Inc..
[4572823]
On (b)(6) 2014, an initial report specified the pt received ossif-i-sem (ossif-i-mineralized cortical/cancellous allograft bowl) small particle bone graft and heliplug. On an unspecified date the pt came down with pneumonia after the procedure. The periodontist did not know if pneumonia was or was not related to the ossif-i, but couldn't say one way or the other for sure. On (b)(6) 2014 customer reports procedure was on (b)(6) 2014 and pneumonia event diagnosed at er, antibiotics prescribed and pt is improving.
Patient Sequence No: 1, Text Type: D, B5
[11911408]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00044 |
| MDR Report Key | 3935897 |
| Report Source | 06 |
| Date Received | 2014-06-20 |
| Date of Report | 2014-06-06 |
| Date of Event | 2014-05-30 |
| Date Mfgr Received | 2014-06-11 |
| Date Added to Maude | 2014-07-28 |
| 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 | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLAGEN PLUG-HELIPLUG |
| Generic Name | M54-ORAL SURGERY |
| Product Code | LPG |
| Date Received | 2014-06-20 |
| Catalog Number | 62-202 |
| Lot Number | 1125141 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-20 |