FDA Adverse Event
Malfunction
Summary report: N
MONOMAX VIOLET 1(4) 150CM HR40S LOOP (M)
MDR report key: 3988163
·
Received April 25, 2014
Report
- Report Number
- 2916714-2014-00298
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 8, 2014
- Report Date
- April 25, 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
REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). A CASE OF CARCINOMA RECTOSIGMOID WITH CORONARY ARTERY DISEASE AND CHRONIC RENAL DISEASE, HAD A BUST ABDOMEN, FIFTH DAY AFTER LAPAROSTOMY AFTER RESECTION, THERE WAS AN ASSOCIATED SOFT TISSUE INFECTION ALSO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252109 | MONOMAX VIOLET 1(4) 150CM HR40S LOOP (M) | SYNTHETIC ABSORBABLE SUTURE | NWJ | B. BRAUN SURGICAL S.A. | B0041077 | 112355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |