FDA Adverse Event
Malfunction
Summary report: N
GUT SURGICAL SUTURE
MDR report key: 1850241
·
Received September 22, 2010
Report
- Report Number
- 2210968-2010-01148
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- July 28, 2010
- Report Date
- August 23, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAL
- PMA / PMN Number
- N10389
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A TONSILLECTOMY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. WHILE THE SURGEON WAS SUTURING NEAR THE BASE OF THE TONGUE, THE NEEDLE BROKE. FLUOROSCOPY WAS REQUIRED TO FIND THE NEEDLE PIECE WHICH WAS REMOVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUT SURGICAL SUTURE | SUTURE, ABSORBABLE | GAL | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |