FDA Adverse Event
Malfunction
Summary report: N
SUPRAMID WHITE 4 (6) 25M
MDR report key: 3970078
·
Received April 28, 2014
Report
- Report Number
- 2916714-2014-00307
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- B BRAUN SURGICAL SA
- Product Code
- GAL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MFR SITE EVALUATION: SAMPLES RECEIVED: 1 OPEN CASSETTE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH FOR THIS ISSUE. DIAMETER RESULT CONDUCTED ON THE SAMPLE RECEIVED IS WITHIN THE AVERAGE AND FULFILS THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THIS PROCESS FULFILL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NA.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). THREAD IS THINNER THAN IN OTHER CASSETTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253434 | SUPRAMID WHITE 4 (6) 25M | SUPRAMID CASSETTES SUTURE | GAL | B BRAUN SURGICAL SA | F1184105 | 110265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |