FDA Adverse Event
Malfunction
Summary report: N
CIRCULAR MECH XL SEAL 21MM
MDR report key: 14117436
·
Received April 15, 2022
Report
- Report Number
- 3005075853-2022-02400
- Event Type
- Malfunction
- Date Received
- April 15, 2022
- Date of Event
- March 2, 2022
- Report Date
- April 15, 2022
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- UDI-DI
- 10705036022916
- PMA / PMN Number
- K983536
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4). BATCH # UNK. MW (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.
Description of Event or Problem · 0
USER FACILITY MW (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2174021 | CIRCULAR MECH XL SEAL 21MM | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | ECS21B | 10705036022916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |