MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-21 for HELIPLUG 62202 manufactured by Integra York Pa Inc.
[18812666]
Customer initially reports two pts had tooth extractions and developed infections. Physician reporting because lots are part of the recall notice received from integra. (b)(6) 2013: doctor provides the following information: patient (b)(6). (b)(6) 2013: presented with complaint of pain on biting upper right side. Radiographic evidence of external resorption db root. Referred to endodontist for eval or treatment (tx). Endo report = non-restorable. Tx: ext, graft for implant. (b)(6) 2013: presented for extraction. Surgical extraction via split root to preserve buccal plate and not reflect tissue. Straumann bone, helioplug, cytoflex 3 x 3. 0 silk. One week suture removal. (b)(6): pt complained of pain and swelling, exudate in extraction site. Debride, irrigate with peridex, and flagyl (amox allergy) for infection. One week follow-up. (b)(6) 2013: healing within normal limits.
Patient Sequence No: 1, Text Type: D, B5
[19219234]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00025 |
| MDR Report Key | 3129827 |
| Report Source | 05 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-04-23 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-05-28 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELIPLUG |
| Generic Name | NA |
| Product Code | LPG |
| Date Received | 2013-05-21 |
| Catalog Number | 62202 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2013-05-21 |