FDA Adverse Event
Injury
Summary report: N
MAXON SUTURE
MDR report key: 89059
·
Received May 7, 1997
Report
- Report Number
- 2648188-1997-00010
- Event Type
- Injury
- Date Received
- May 7, 1997
- Date of Event
- March 11, 1997
- Report Date
- April 2, 1997
- Manufacturer
- DAVIS & GECK, INC.
- Product Code
- GAM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TWO BOXES OF SAMPLES WERE RETURNED FOR EVALUATION. KNOT PULL STRENGTH TESTS WERE WITHIN ACCEPTABLE STANDARDS. IN VIVO TESTS WERE PERFORMED AND SUTURES PERFORMED AS EXPECTED. CO'S FINDINGS INDICATE THAT UNDER NORMAL CONDITIONS OF USE, THIS PRODUCT SHOULD HAVE PERFORMED SATISFACTORILY.
Description of Event or Problem · 1
MAXON SUTURE WAS USED FOR PFANNENSTIEL CLOSURE OF ABDOMEN FOLLOWING C-SECTION, THE SUTURE BROKE FOUR DAYS POST OP RESULTING IN A DEHISCENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXON SUTURE Implant | SURGICAL SUTURE | GAM | DAVIS & GECK, INC. | NA | 947491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |