FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 1131563
·
Received August 9, 2008
Report
- Report Number
- 2020550-2008-00018
- Event Type
- Other
- Date Received
- August 9, 2008
- Date of Event
- July 8, 2008
- Report Date
- August 7, 2008
- Manufacturer
- D & R PRODUCTS CO.
- Product Code
- HTT
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DR WAS PERFORMING A SUBCROMIAL COMPRESSION ON THE LEFT SHOULDER; ALLEGEDLY, AFTER REMOVING BURR AND BEFORE SWITCHING TO ANOTHER, DR NOTICED WHAT APPEARED TO BE A 3" X 8MM SIZED ABRASION ON THE LEFT SHOULDER. ABRASION MAY BE A RESULT OF BURR HEAD COMING INTO CONTACT WITH SHOULDER WHEN REMOVED FROM PT. NO MEDICAL ATTENTION WAS NECESSARY FOR THE ABRASION OTHER THAN WHAT IS USED ROUTINELY AT THE END OF THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO OTHER PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | DISPOSABLE BURR | HTT | D & R PRODUCTS CO. | 28205HDS | 23980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |