FDA Adverse Event
Malfunction
Summary report: N
PCO VENTRAL PATCH 4C
MDR report key: 4134484
·
Received October 2, 2014
Report
- Report Number
- 9615742-2014-00313
- Event Type
- Malfunction
- Date Received
- October 2, 2014
- Date of Event
- October 3, 2013
- Report Date
- September 9, 2014
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OXJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4). ACCORDING TO THE REPORTER, THE ORIGINAL PROCEDURE WAS A HERNIA REPAIR. THE "RECURRENCE" DESCRIBED IN THE INITIAL REPORT WAS A RECURRENCE OF HERNIA.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER:PATIENT CAME TO HOSPITAL ON (B)(6), BECAUSE IF SUIGNS OF RECURRANCE. RECURRENCE DIANOSED BY PHYSICAL EXAMINATION AND ULTRASOUND. FOR THE MOMENT CONSERVATIVE TREATMENT. NO OPERATION MEDICAL HISTORY: COPD, HYPERTHYROID, PSORIASIS, HEARTBURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614631 | PCO VENTRAL PATCH 4C | PCO VENTRAL PATCH | OXJ | SOFRADIM PRODUCTION | PCO4VP | PND0716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |