FDA Adverse Event
Injury
Summary report: N
SPRAYSHIELD POLYMER KIT WITH SPRAYER
MDR report key: 1668094
·
Received April 19, 2010
Report
- Report Number
- 3003157248-2010-00008
- Event Type
- Injury
- Date Received
- April 19, 2010
- Report Date
- March 8, 2010
- Manufacturer
- CONFLUENT
- Product Code
- NQR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
PROCEDURE: LAPAROSCOPIC REMOVAL OF ENDOMETRIOSIS. ACCORDING TO THE REPORTER: THE PATIENT PRESENTED 24 HOURS POST-OPERATIVELY WITH ACUTE ABDOMEN AND RAISED INFLAMMATORY MARKERS. THERE WAS NO BOWEL OR BLADDER DAMAGE AND NO SEPSIS. MICRO RESULTS WERE NEGATIVE. THE PATIENT WAS RELAPAROSCOPIED TO CHECK FOR BOWEL/BLADDER DAMAGE AND NONE WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRAYSHIELD POLYMER KIT WITH SPRAYER | CONFLUENT SPRAYSHIELD KIT | NQR | CONFLUENT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |