MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for HELIMEND 15 X 20 62-203 manufactured by Integra York, Pa Inc..
[145483755]
The device was not returned to the manufacturer for evaluation, therefore the failure mode could not be confirmed. There were no deviations or non-conformances during the manufacturing process. The device history record review was not possible since no lot number was reported. The reported complaint is a user error. Device identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145483756]
A nurse reported to integra that on (b)(6) 2019, a 62-203 helimend 15 x 20, the dentist placed the helimend in the patient? S mouth, placed/stitched the helimend membrane template cut-out into the patient? S mouth as an additional product. Patient was sent home. The nurse inquired in behalf of the care team if integra would approve of the packaging/template cut-out being left in the patient mouth. The nurse was informed via phone conversation with integra medical affairs manager that the template is not intended for implantation and must be discarded following modification of the helimend membrane, per the instructions for use (ifu). The nurse indicated that the assistant working with the dentist handed the entire envelope/package instead of just the product. It is unknown of the removal date of product (revision) and injury. It is unknown if there was any surgical delay. Request for additional information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00068 |
| MDR Report Key | 8622010 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-17 |
| 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 Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HELIMEND 15 X 20 |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | LYC |
| Date Received | 2019-05-17 |
| Catalog Number | 62-203 |
| 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 | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |