FDA Adverse Event
Malfunction
Summary report: N
MONOMAX VIOLET 1(4) 150CM HR48 LOOP (M)
MDR report key: 3880696
·
Received May 28, 2014
Report
- Report Number
- 2916714-2014-00392
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 29, 2014
- Report Date
- May 28, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- NWJ
- PMA / PMN Number
- K100876
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING AT MANUFACTURING SITE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). CLOSING NEPHROSTOMY. DESCRIPTION OF THE INCIDENT. PASSING THE FIRST ITEM AND ITS BUSTING PULLING. THIS HAPPENS DURING FIELD WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313863 | MONOMAX VIOLET 1(4) 150CM HR48 LOOP (M) | SYNTHETIC ABSORBABLE SUTURE | NWJ | B. BRAUN SURGICAL S.A. | B0041222 | 112184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |