MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-07-01 for OWENS AND MINOR, INC. MEDICHOICE TOURNIQUET TRN1184 manufactured by Avcor Health Care Products, Inc..
[3572353]
One pt involved. Pt identifier - marked confidential. On 06/28/2013, uf/importer report (b)(4) filed with the fda on (b)(4) 2013, was received by avcor at the above mentioned (b)(4)address. (b)(4), official correspondent to avcor, was contacted and then inquired with avcor for more info concerning this report on 06/29/2013. This response by avcor, dated on 06/30/2013, will be mailed to the fda on 07/01/2013 by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10996659]
According to uf/importer report (b)(4) report filed the brand name as avc x-tourn when, in fact, the catalogue number indicated (trn1184) is an owens and minor, inc. Medichoice labeled medical device (part of owens and minor, inc mainstream program to the best of our knowledge). The avcor contact info (including name, e-mail, web-site, telephone / fax numbers, etc. ) does not appear on any of the medchoice labeling, inserts, etc. This scenario does not follow documentation logic, i. E. Capital region med ctr would not have known about avcor; the lack of correlation between the brand name and catalogue number. Avcor will continue to pursue getting the device in question back for investigatory purposes. If the device in question is received by avcor and investigation will ensue and this medical device report 1649245-2013-00001 will be summarily updated. Avcor will seek to acquire as much info as possible to bring closure to this medwatch report 1649245-2013-00001. It is important to note that the date of the incident was (b)(6) 2013, the date of the report by (b)(6) is (b)(6) 2013, the date that the report was sent to the fda is indicated as 06/xx/2013. Avcor received report # (b)(4) on 06/28/2013 and filed a report with the fda post marked on 07/01/2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649245-2013-00001 |
| MDR Report Key | 3224767 |
| Report Source | 01 |
| Date Received | 2013-07-01 |
| Date of Report | 2013-06-30 |
| Date of Event | 2013-05-17 |
| Date Mfgr Received | 2013-06-28 |
| Date Added to Maude | 2013-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2320 MICHIGAN CT |
| Manufacturer City | ARLINGTON TX 76016 |
| Manufacturer Country | US |
| Manufacturer Postal | 76016 |
| Manufacturer Phone | 8002826748 |
| Manufacturer G1 | GARWARE BESTRETCH LTD |
| Manufacturer Street | BUND GARDEN RD, 4TH FLR, PLOT #D2 |
| Manufacturer City | PUNE, MAHARASHTRA 411001 |
| Manufacturer Country | IN |
| Manufacturer Postal Code | 411001 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OWENS AND MINOR, INC. MEDICHOICE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2013-07-01 |
| Model Number | TRN1184 |
| Catalog Number | TRN1184 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVCOR HEALTH CARE PRODUCTS, INC. |
| Manufacturer Address | 2320 MICHIGAN CT ARLINGTON TX 76016 US 76016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-01 |