FDA Adverse Event
Malfunction
Summary report: N
CATGUT CHROMIC 2/0 (3.5) 100M
MDR report key: 4213905
·
Received October 6, 2014
Report
- Report Number
- 2916714-2014-00773
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Report Date
- October 6, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAL
- PMA / PMN Number
- K991223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 1 OPEN CASSETTE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE (B)(4) UNITS IN OEM STOCK. TESTED THE KNOT PULL TENSILE STRENGTH OF THE CASSETTE RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). THREAD TEARS TOO EASILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625161 | CATGUT CHROMIC 2/0 (3.5) 100M | ABSORBABLE SUTURE | GAL | B. BRAUN SURGICAL S.A. | F1154052 | 613514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |