FDA Adverse Event
Malfunction
Summary report: N
MONO-DOX
MDR report key: 17872208
·
Received October 4, 2023
Report
- Report Number
- 3012164473-2023-00003
- Event Type
- Malfunction
- Date Received
- October 4, 2023
- Date of Event
- March 9, 2022
- Report Date
- October 4, 2023
- Manufacturer
- CP MEDICAL
- Product Code
- NEW
- UDI-DI
- 01079098600115
- PMA / PMN Number
- K013274
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UDI RELATED DATA QUALITY UPDATES ONLY.
Description of Event or Problem · 0
A COMPLAINT WAS RECEIVED REGARDING PART NUMBER: M398, LOT: 211022-56, SIZE: 3/0 PDO SWAGE SUTURE. THE CUSTOMER STATED THAT THE SUTURES HAD NO TENSILE STRENGTH AND WOULD EASILY BREAK JUST BY INSERTING THE SUTURE THROUGH THE SKIN. THE CUSTOMER FURTHER STATED THAT MANY SURGERIES WERE PERFORMED, AND THAT BREAKAGES OCCURRED DURING PROCEDURES. ACCORDING TO THE CUSTOMER, MOST WERE FOR CLOSING OFF INCISIONS. THE PROVIDER MENTIONED SEVERAL PATIENTS INVOLVED, BUT AN ACTUAL COUNT WAS NOT PROVIDED; THERE WERE NO REPORTS OF DELAYS IN THE PROCEDURES GREATER THAN 30 MINUTES. NO FURTHER INFORMATION WAS OBTAINED FROM THE CLINIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2271027 | MONO-DOX | (M398) MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE | NEW | CP MEDICAL | M398 | 211022-56 | 01079098600115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |