PROLARYN PLUS
Report
- Report Number
- 3013840437-2025-00121
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Report Date
- September 8, 2025
- Manufacturer
- MERZ NORTH AMERICA, INC (FRANKSVILLE)
- Product Code
- KHJ
- UDI-DI
- M2138044M4K55
- PMA / PMN Number
- K013243
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE BATCH RECORD REVIEW FOR PROLARYN PLUS, LOT A00140080, CONTAINS NONCONFORMANCE REPORTS OR CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT, BUT NONE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED ON THE REPORTED LOT (BATCH A00140080) AND NO SIMILAR EVENTS WERE NOTED. ASSESSMENT BY MERZ: THE EVENT OCCURRED IN A COMPATIBLE TEMPORAL AND LOCAL RELATIONSHIP. FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE (SERIOUS) IS UNEXPECTED BASED ON CURRENTLY VALID CANADIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF PROLARYN PLUS. NEEDLE ISSUE IS ONLY CODED FOR FORMAL REASONS. THE REPORTED NEEDLE ISSUE IS CONSIDERED REPORTABLE BECAUSE IT HAS RESULTED IN A SERIOUS ADVERSE EVENT IN THIS CASE AND ALSO COULD HAVE RESULTED IN A SERIOUS ADVERSE EVENT IF IT WERE TO RECUR. POSSIBLE CONFOUNDING FACTOR INCLUDES THE NEEDLE ISSUE, BUT SPARSE INFORMATION WAS PROVIDED. IN THIS CASE, SURGICAL INTERVENTION WAS PERFORMED WITH A RESOLVED OUTCOME. CAUSALITY FOR THE EVENT IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH PROLARYN PLUS BASED ON COMPATIBLE LOCAL AND TEMPORAL RELATIONSHIP. THIS CASE IS SERIOUS WITH THE SERIOUS EVENT FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE DUE TO NEEDLE ISSUE WHICH REQUIRED SURGICAL INTERVENTION TO PREVENT A PERMANENT DAMAGE.
THE BATCH RECORD REVIEW FOR PROLARYN PLUS, LOT A00140080, CONTAINS NONCONFORMANCE REPORTS OR CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT, BUT NONE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED ON THE REPORTED LOT (BATCH A00140080) AND NO SIMILAR EVENTS WERE NOTED. ASSESSMENT BY MERZ: THE EVENT OCCURRED IN A COMPATIBLE TEMPORAL AND LOCAL RELATIONSHIP. FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE (SERIOUS) IS UNEXPECTED BASED ON CURRENTLY VALID CANADIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF PROLARYN PLUS. NEEDLE ISSUE IS ONLY CODED FOR FORMAL REASONS. THE REPORTED NEEDLE ISSUE IS CONSIDERED REPORTABLE BECAUSE IT HAS RESULTED IN A SERIOUS ADVERSE EVENT IN THIS CASE AND ALSO COULD HAVE RESULTED IN A SERIOUS ADVERSE EVENT IF IT WERE TO RECUR. POSSIBLE CONFOUNDING FACTOR INCLUDES THE NEEDLE ISSUE, BUT SPARSE INFORMATION WAS PROVIDED. IN THIS CASE, SURGICAL INTERVENTION WAS PERFORMED WITH A RESOLVED OUTCOME. CAUSALITY FOR THE EVENT IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH PROLARYN PLUS BASED ON COMPATIBLE LOCAL AND TEMPORAL RELATIONSHIP. THIS CASE IS SERIOUS WITH THE SERIOUS EVENT FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE DUE TO NEEDLE ISSUE WHICH REQUIRED SURGICAL INTERVENTION TO PREVENT A PERMANENT DAMAGE. MERZ CAUSALITY RE-ASSESSMENT AFTER AMENDMENT WAS PERFORMED ON (B)(6) 2025: AE+PC WAS ADDED TO THE CATEGORY ON THE GENERAL TAB AND MALFUNCTION FIELD ON THE DEVICE INFORMATION TAB WAS TICKED WITH YES. CAUSALITY FOR THE PREVIOUSLY REPORTED EVENT REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH PROLARYN PLUS BASED ON COMPATIBLE LOCAL AND TEMPORAL RELATIONSHIP. THIS CASE IS STILL CONSIDERED SERIOUS WITH THE SERIOUS EVENT FOREIGN BODY IN SKIN OR SUBCUTANEOUS TISSUE DUE TO NEEDLE ISSUE WHICH REQUIRED SURGICAL INTERVENTION TO PREVENT A PERMANENT DAMAGE.
CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CANADIAN HEALTH CARE PROFESSIONAL AND CONCERNS A MALE PATIENT. THE PATIENT WAS INJECTED WITH PROLARYN PLUS INTO THE ANTERIOR PORTION OF THE NECK TO ACCESS VOCAL CORDS, FOR VOCAL CORD PARALYSIS. BATCH NUMBER WAS REPORTED AS A00140080 (EXPIRY DATE: 31-OCT-2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR PROLARYN PLUS WAS CONFIRMED AS A00140080 (EXPIRY DATE: 31-OCT-2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. PROLARYN PLUS WAS INJECTED USING A NEEDLE. A SYRINGE OF PROLARYN PLUS WAS USED FOR THE INJECTION OF THE LEFT VOCAL CORD. THE PROCEDURE WAS PERFORMED BY AN OTOLARYNGOLOGIST UNDER LOCAL ANESTHESIA, WHILE A NURSE PRACTITIONER SIMULTANEOUSLY CONDUCTED RHINOSCOPY WITH A VIDEOSCOPE TO VISUALIZE THE INJECTION SITE. DURING THE INJECTION, THE NEEDLE SHAFT BROKE OFF AT THE HUB (NEEDLE ISSUE). AFTER THE PROLARYN PLUS INJECTION, THE PATIENT EXPERIENCED THAT THE NEEDLE EMBEDDED INTO HIS NECK AFTER THE NEEDLE SHAFT BROKE OFF AT THE HUB. THE PHYSICIAN DISCONTINUED THE INJECTION, AND THE PATIENT WAS MOVED TO STRETCHER. SURGICAL INTERVENTION WAS REQUIRED. AN INCISION WAS MADE INTO THE ANTERIOR NECK, AND THE NEEDLE SHAFT WAS RETRIEVED UNDER LOCAL ANESTHESIA BY THE PHYSICIAN. THE INCISION WAS CLOSED WITH ABSORBABLE SUTURES AND COVERED WITH STERI-STRIPS. THE PATIENT WAS SCOPED AGAIN TO ASSESS ADVERSE EFFECTS. HE REMAINED IN CLINIC FOR 1 HOUR, AGAIN SCOPED TO ENSURE NO ACTIVE BLEEDING OR ADVERSE EFFECTS. THE PATIENT TOLERATED THE INCIDENT WELL, AND REMAINED CALM. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED.
CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CANADIAN HEALTH CARE PROFESSIONAL AND CONCERNS A MALE PATIENT. THE PATIENT WAS INJECTED WITH PROLARYN PLUS INTO THE ANTERIOR PORTION OF THE NECK TO ACCESS VOCAL CORDS, FOR VOCAL CORD PARALYSIS. BATCH NUMBER WAS REPORTED AS A00140080 (EXPIRY DATE: 31-OCT-2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR PROLARYN PLUS WAS CONFIRMED AS A00140080 (EXPIRY DATE: 31-OCT-2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. PROLARYN PLUS WAS INJECTED USING A NEEDLE. A SYRINGE OF PROLARYN PLUS WAS USED FOR THE INJECTION OF THE LEFT VOCAL CORD. THE PROCEDURE WAS PERFORMED BY AN OTOLARYNGOLOGIST UNDER LOCAL ANESTHESIA, WHILE A NURSE PRACTITIONER SIMULTANEOUSLY CONDUCTED RHINOSCOPY WITH A VIDEOSCOPE TO VISUALIZE THE INJECTION SITE. DURING THE INJECTION, THE NEEDLE SHAFT BROKE OFF AT THE HUB (NEEDLE ISSUE). AFTER THE PROLARYN PLUS INJECTION, THE PATIENT EXPERIENCED THAT THE NEEDLE EMBEDDED INTO HIS NECK AFTER THE NEEDLE SHAFT BROKE OFF AT THE HUB. THE PHYSICIAN DISCONTINUED THE INJECTION, AND THE PATIENT WAS MOVED TO STRETCHER. SURGICAL INTERVENTION WAS REQUIRED. AN INCISION WAS MADE INTO THE ANTERIOR NECK, AND THE NEEDLE SHAFT WAS RETRIEVED UNDER LOCAL ANESTHESIA BY THE PHYSICIAN. THE INCISION WAS CLOSED WITH ABSORBABLE SUTURES AND COVERED WITH STERI-STRIPS. THE PATIENT WAS SCOPED AGAIN TO ASSESS ADVERSE EFFECTS. HE REMAINED IN CLINIC FOR 1 HOUR, AGAIN SCOPED TO ENSURE NO ACTIVE BLEEDING OR ADVERSE EFFECTS. THE PATIENT TOLERATED THE INCIDENT WELL, AND REMAINED CALM. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED. AMENDMENT WAS PERFORMED ON (B)(6) 2025: AE+PC WAS ADDED TO THE CATEGORY ON THE GENERAL TAB AND MALFUNCTION FIELD ON THE DEVICE INFORMATION TAB WAS TICKED WITH YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1823617 | PROLARYN PLUS | POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) | KHJ | MERZ NORTH AMERICA, INC (FRANKSVILLE) | A00140080 | M2138044M4K55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |