FDA Adverse Event
Injury
Summary report: N
TIELLE PLUS SACRUM HYDROPOLYMER ADHESIVE DRES
MDR report key: 4216382
·
Received October 27, 2014
Report
- Report Number
- 3007663067-2014-00002
- Event Type
- Injury
- Date Received
- October 27, 2014
- Date of Event
- September 25, 2014
- Report Date
- September 25, 2014
- Manufacturer
- SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED SKIN BREAKDOWN IS RELATED TO TIELLE PLUS SACRUM HYDROPOLYMER ADHESIVE DRESSING. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFO, BUT THERE HAS BEEN NO RESPONSE. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE.
Description of Event or Problem · 1
ON (B)(6) 2014, THE FOLLOWING INFO WAS REPORTED TO SYSTAGENIX BY THE DISTRIBUTION REP: THE CUSTOMER ALLEGED THE TIELLE PLUS SACRUM HYDROPOLYMER ADHESIVE DRESSING WAS "BREAKING DOWN HER SKIN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681765 | TIELLE PLUS SACRUM HYDROPOLYMER ADHESIVE DRES | TIELLE PLUS SACRUM HYDROPOLMER | FRO | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |