MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-11 for MEDICHOICE LATEX FREE STOCKINETTE STK3648 manufactured by Medichoice / Owens & Minor.
[2352207]
Foreign material discovered inside of a sterile stockinette pack while pack was in channel of distribution. Foreign material: appears to be a clump of lint approximately 15 mm x 10 mm. Spd (sterile processing department) technician discovered problem and removed product from distribution. Jpg photo can be forwarded. (please advise reporter of e-mail address; jpg will be sent out. )no patient adverse event arose since problem was discovered prior to any patient contact. ======================manufacturer response for sterile stockinette, medichoice latex free stockinette (per site reporter). ======================no response as of this time. Sent e-mail to sales rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2344270 |
| MDR Report Key | 2344270 |
| Date Received | 2011-11-11 |
| Date of Report | 2011-11-11 |
| Date of Event | 2011-11-11 |
| Report Date | 2011-11-11 |
| Date Reported to FDA | 2011-11-11 |
| Date Added to Maude | 2011-11-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE LATEX FREE STOCKINETTE |
| Generic Name | STERILE STOCKINETTE |
| Product Code | IPM |
| Date Received | 2011-11-11 |
| Model Number | STK3648 |
| Catalog Number | STK3648 |
| Lot Number | 211211 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICHOICE / OWENS & MINOR |
| Manufacturer Address | 9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-11 |