FDA Adverse Event
Malfunction
Summary report: N
MONOMAX VIOLET 1(4) 150CM HRT48 LOOP (M)
MDR report key: 3821500
·
Received January 15, 2014
Report
- Report Number
- 2916714-2014-00037
- Event Type
- Malfunction
- Date Received
- January 15, 2014
- Report Date
- January 15, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- MPN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON (B)(4) 2013. REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 UNOPENED BOX WITH 24 POUCHES. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKETS RECEIVED ARE TIGHT. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE IN ACCORDANCE WITH OEM SPECIFICATION. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED).
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKS OFTEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40433 | MONOMAX VIOLET 1(4) 150CM HRT48 LOOP (M) | NONE | MPN | B. BRAUN SURGICAL S.A. | B0041222 | 112465V004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |