FDA Adverse Event
Injury
Summary report: N
SUNMED LLC
MDR report key: 17083133
·
Received June 7, 2023
Report
- Report Number
- 1314417-2023-00013
- Event Type
- Injury
- Date Received
- June 7, 2023
- Date of Event
- May 18, 2023
- Report Date
- June 7, 2023
- Manufacturer
- SECURISYN MEDICAL
- Product Code
- CBH
- UDI-DI
- 00860009077928
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 117
Narratives
Additional Manufacturer Narrative · 0
THE S-FLEX BREAKING COULD CAUSE THE SMALL PIECE TO BECOME A CHOKING HAZARD.
Additional Manufacturer Narrative · 0
THE S-FLEX BREAKING COULD CAUSE THE SMALL PIECE TO BECOME A CHOKING HAZARD. SUMMARY: INVESTIGATION INTO REPORTED COMPLAINTS (B)(4) INDICATE A LACK OF SYSTEM REQUIREMENTS DURING DESIGN AND PRODUCT LAUNCH. REVISION OF THE DESIGN INPUT/OUTPUT FILES ARE BEING CONDUCTED FOR AIRLIFE PRODUCT ACQUISITION. RA: NO ASSOCIATED RISK MANAGEMENT FILES FOR SOLIDAIRITY PRODUCT OWNED BY AIRLIFE AT TIME OF CLINICAL TRIALS.
Description of Event or Problem · 0
S-FLEX HAD BROKEN WHERE THE TOWER MEETS THE LATERAL SLIDE.
Description of Event or Problem · 0
S-FLEX HAD BROKEN WHERE THE TOWER MEETS THE LATERAL SLIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331205 | SUNMED LLC | SOLIDAIRITY FLEX ORAL ENDOTRACHEAL TUBE STABILIZER | CBH | SECURISYN MEDICAL | 4.1500.2DS | SY230206 | 00860009077928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |