FDA Adverse Event
Injury
Summary report: N
SUPERFLEX SOFT TISSUE RETRACTOR,SPATULA SHAPED, 25X200MM
MDR report key: 16021118
·
Received December 21, 2022
Report
- Report Number
- 9615005-2022-12001
- Event Type
- Injury
- Date Received
- December 21, 2022
- Date of Event
- November 24, 2022
- Report Date
- December 21, 2022
- Manufacturer
- FEHLING INSTRUMENTS GMBH & CO. KG
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN ASSISTANT
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NO PATIENT WAS HARMED.
Description of Event or Problem · 0
IT WAS FOUND INTRAOPERATIVELY THAT THE SOFT TISSUE RETRACTOR WAS DEFECTIVE. THE PATIENT WAS NOT HARMED. AFTER THE RETRACTOR WAS RETURNED TO THE MANUFACTURER ON DECEMBER 9, INSPECTION OF THE RETRACTOR REVEALED THAT A PIECE OF THE RETRACTOR HAD BROKEN OUT. HOWEVER, THIS BROKEN PIECE WAS NOT FOUND IN THE PATIENT NOR OUTSIDE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476101 | SUPERFLEX SOFT TISSUE RETRACTOR,SPATULA SHAPED, 25X200MM | SOFT TISSUE RETRACTOR | GAD | FEHLING INSTRUMENTS GMBH & CO. KG | MTI-0 | 29140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |