FDA Adverse Event
Other
Summary report: N
MONOSOF SUTURE
MDR report key: 17827738
·
Received September 26, 2023
Report
- Report Number
- MW5146215
- Event Type
- Other
- Date Received
- September 26, 2023
- Date of Event
- September 21, 2023
- Report Date
- September 22, 2023
- Manufacturer
- COVIDIEN
- Product Code
- GAR
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SUTURE BROKE IN HALF WHILE PA WAS SUTURING. NO HARM TO PATIENT. MONOSOF SN- (B)(6) LOT # D3D1585FY SUTURE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416903 | MONOSOF SUTURE | SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | GAR | COVIDIEN | D3D1585FY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |