FDA Adverse Event
Injury
Summary report: N
PERMA-SEAL
MDR report key: 227024
·
Received June 8, 1999
Report
- Report Number
- 2183460-1999-00015
- Event Type
- Injury
- Date Received
- June 8, 1999
- Date of Event
- May 6, 1999
- Report Date
- June 7, 1999
- Manufacturer
- POSSIS MEDICAL, INC.
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT (FEMALE, 56 YRS OLD) DEVELOPED SEVERE STEAL SYNDROME CAUSING NEUROPATHY AND THREATENED LIMB LOSS OF RIGHT HAND. GRAFT WAS LIGATED TO PREVENT FURTHER DAMAGE. PRODUCT NOT AVAILABLE FOR RETURN. PHYSICIAN WOULD LIKE A RECOMMENDATION FOR SOLUTION. CATHETER WAS PLACED AFTER GRAFT LIGATED (TIED OFF). PT. WAS DIABETIC AND OVERWEIGHT. PHYSICIAN CONCERNED BECAUSE HE'S "IMPLANTED OVER 150 GRAFTS AND THIS IS THE 1ST HE'S SEEN WITH THIS TYPE OF RESULT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERMA-SEAL Implant | A-V GRAFT | DSY | POSSIS MEDICAL, INC. | PS | 014350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | UNKNOWN AT THIS TIME |