MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR COLLAPLUG; DENTAL PRODUCTS

Model Number	REV2/09
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported "severe swelling" after collaplug use: per assistant: "on (b)(6) 2023 doctor did an extraction and placed some oraplug in the extraction site.The patient very soon after experienced "severe swelling" that extended across her lip from corner to corner.They have ruled out other possible causes, i.E., the antibiotic, anesthesia etc.And they are wondering about the oraplug.I asked how the patient was currently and she said she is improving".
Additional Manufacturer Narrative
The customer identified two lot numbers as the possible products involved in the reported event: lot number: 6367264 expiration date: 04/30/2025.Lot number: 6533470 expiration date: 07/31/2025.Collaplug (id oraplugpkg-10) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: COLLAPLUG
• Common Device Name: DENTAL PRODUCTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16725500
• Report Number: 2648988-2023-00010
• Device Sequence Number: 18139814
• Product Code: LPG
• UDI-Device Identifier: 00841336100886
• UDI-Public: 00841336100886
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: REV2/09
• Device Catalogue Number: ORAPLUGPKG-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown