FDA Adverse Event
Malfunction
Summary report: N
CATGUT CHROM 1 (5) 90CM HR37S
MDR report key: 3970155
·
Received April 29, 2014
Report
- Report Number
- 2916714-2014-00314
- Event Type
- Malfunction
- Date Received
- April 29, 2014
- Date of Event
- February 28, 2014
- Report Date
- April 29, 2014
- Manufacturer
- B BRAUN SURGICAL S.A.
- Product Code
- GAL
- PMA / PMN Number
- K991223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVAL: EVAL ON-GOING AT MANUFACTURING SITE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKS AND FRAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255574 | CATGUT CHROM 1 (5) 90CM HR37S | SOFTCAT SUTURE | GAL | B BRAUN SURGICAL S.A. | B0565121 | 513192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |