FDA Adverse Event
Injury
Summary report: N
MAXON
MDR report key: 2210053
·
Received August 3, 2011
Report
- Report Number
- 1219930-2011-00646
- Event Type
- Injury
- Date Received
- August 3, 2011
- Report Date
- July 5, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K990951
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REF MDR #S OF OTHER 6 CASES: 1219930-2011-00644, 00645, 00615, 00647, 00648, 00649.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING SEVEN CASES SUTURE WAS USED WHICH LED TO WOUND DEHISCENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXON | ABSORBABLE SUTURING PRODUCT | GAM | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |