FDA Adverse Event
Malfunction
Summary report: N
MONOMAX VIOLET 1 (4) 150CM HR48 LOOP (M)
MDR report key: 3938926
·
Received June 13, 2014
Report
- Report Number
- 2916714-2014-00420
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- June 9, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- NWJ
- PMA / PMN Number
- K100876
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: WAITING FOR PRODUCT RETURN.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). MONOMAX LOOP HAS VERY POOR TENSILE STRENGTH, SUTURE MATERIAL BREAKS DURING THIRD THROW OF KNOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351303 | MONOMAX VIOLET 1 (4) 150CM HR48 LOOP (M) | SYNTHETIC ABSORBABLE SUTURE | NWJ | B. BRAUN SURGICAL S.A. | B0041119 | 1123825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |