MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-16 for COLLAGEN PLUG - HELIPLUG 3/8 X 3/4 (1CM X 2CM) 62-202 manufactured by Integra York, Pa Inc..
[4664559]
Customer stating he is having allergic reaction to heli-plug. Heli-plug is used to control bleeding and develop blood clots in extraction sites. On (b)(6) 2014, dentist performed four extractions, socket preservation bone grafting and delivered flippers. (b)(6) 2014: dentist reports healing looks very good. (b)(6) 2014: patient's wife reports that her husband has been in backcountry of (b)(6) since last seen by dentist. When patient flew back from (b)(6) got severe heart burn (has been treated for that in the past). Has a rash all over body that started after return from (b)(6). Patient was admitted to hospital having a severe allergic reaction. Wife asked if this could be a reaction to bone grafting. Dentist told her that he did not know any incidence of allergic reaction but would check with manufacturers. (no mdrs for this product). Since no swelling or irritation of gum tissue dentist feels this is highly unlikely. Dentist discussed possibility of allergy to flipper. Usually there would be contact inflammation and this was not seen.
Patient Sequence No: 1, Text Type: D, B5
[12076509]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00035 |
| MDR Report Key | 3919125 |
| Report Source | 06 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-05-23 |
| Date of Event | 2014-05-22 |
| Date Mfgr Received | 2014-05-23 |
| Date Added to Maude | 2014-07-09 |
| 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 3/8 X 3/4 (1CM X 2CM) |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | LPG |
| Date Received | 2014-06-16 |
| Catalog Number | 62-202 |
| Lot Number | 1134645 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization | 2014-06-16 |